The premier position that India enjoys in the international pharma market is a result of the government support and the talent pool that the country possesses. With continuous government support, the pharma industry has the potential to achieve greater glories.

However, at the domestic level, the situation is not that glorious. This is shown recently when the National Medical Commission decided to put on hold its August 8 rule mandating doctors to prescribe only generic drugs. Indeed, that decision was based on some illusions about the availability of generic and branded medicines in India and not on facts per se. What are the facts? Let’s try to crack the code.

Growth of the Indian pharma industry

Initially, after independence, the main focus was twofold:

1. Not to depend on MNCs for the manufacture and provision of all essential medicines, including antibiotics.
2. So, the government shouldered the responsibility of manufacturing all basic essential antibiotics and medicines. This led to the establishment of Public Enterprises like Hindustan Antibiotics, I.D.P.L., Karnataka Antibiotics, and Bengal Immunity, etc. The main reason for this was that initially, private entrepreneurs were least interested in investing in this capital-intensive industry. This move unburdened the private pharma companies allowing them to concentrate and strengthen their base, and they succeeded in gaining a national as well as international market presence as “global generic medicine manufacturers.”

After shifting the focus to a “market-based economy,” the government’s medicine policies became more liberal, generous, and pro-industry. Though these one-sided pro-industry policies led to the creation of a strong base of around 11,000 pharma units in the country, it happened at the cost of lax regulation on the industry. The government literally showered private owners with all sorts of liberties in licensing, manufacturing standards, and marketing, without putting strong regulations in place. This can be seen from the following few incentives provided by the government, some of which are unique to India.

Various options for licensing manufacturing, marketing, and outsourcing

The industry is allowed to manufacture medicine either on its own license or can have a simple marketing license and get all products manufactured on an outsourcing or third-party basis. Various options for outsourcing have been made available as per the industry’s needs.

• Loan License – Using third-party premises on a loan and hire basis.
• P to P License – Using premises and manpower exclusively.
• Third-Party License – Open for all manufacturers.

As a result, presently, there are about 11,000 manufacturing units, out of which only 300 are actively marketing products, while the rest are being used as third-party manufacturing units.

Various options for manufacturing using different standards of GMP

The industry has a wide choice of options to manufacture a particular generic or brand medicine using the following three standards of manufacturing:

A) cGMP standards for strict regulatory markets – These are the highest standards of quality, where there is continuous up-gradation and stringent regulations. This is required to be adhered to if Indian manufacturers wish to export their generic/ brand medicines to Developed Countries such as the EU, US, Japan, Canada, Australia, etc.

B) WHO-GMP standards for soft-regulatory markets – These are good standards of quality, and standards are updated by WHO every two years. This is required for export to Developing Countries in South East Asia, Middle Eastern countries, and a few African countries.

C) Domestic GMP with accepted diluted standards of quality, as no regular upgradation to global standards is mandatory. This is needed for domestic marketing and for import to countries where there is a weak or absent regulation, e.g., underdeveloped countries like Gambia, Zambia, Yemen, Somalia, Nigeria, etc.

Various options to market medicines using brand names for generics

Once the patent has expired, medicines are marketed either by their generic names or by branded names given by the companies. With the various options for marketing provided above, currently, only 10 per cent of the drugs in the domestic market are unbranded/generic, mostly procured by Public Health care services. The rest, around 87 per cent of drugs dispensed in India, are so-called Branded, Branded generics, Mirror brands, etc. As a result, the market is flooded with the same medicines under thousands of brand names. ¹

• Currently, as per a study done by Competition Commission of India, it was revealed that during 2011-2012, 47,478 brands were available with 2,871 formulations marketed in India, with an average of 17 brands for every formulation.
• Vitamins/minerals and sex stimulants display higher brand creation. Vitamin formulations have, on average, 37 brands, and sex stimulants have 19 brands per formulation.
• In the case of vaccines and anti-neoplastic medication, it requires high standards and more capital investments, resulting in the lowest brand creation, with only five and seven brands per formulation, respectively.¹

Unrestrained merrymaking game of brand names

Surprisingly, even today, there is no central database of all brand names available in India. Companies only need to provide an undertaking to the drug regulatory authority stating that a particular brand is not used by any other company in India. As a result, during 2011—2012, approximately 235 drug brands were introduced monthly, with a total value of Rs. 318 crores. Annually, about 2,827 brands with a total value of Rs. 3,810 crores were introduced. The number of brands varies considerably even between different strengths and doses.

• In the anti-diabetes category, the popular combination of glimepiride + metformin (Tablet, 500 mg) remained the top, with about 137 brands from 120 companies.
• Rosuvastatin (Tablet, 10 mg), a cholesterol-lowering agent, was marketed through 127 brands by 105 companies.

Indian Jugaad – Mirror brands and interchangeability of brands of the same company

Normally, it is expected to have the same brand name for the same generic by the “Same Company.” However, in India, companies are allowed to have “Different brands for the same generic marketed by the same company.” This is called “Mirror Brand.”¹

• There are five to six different brands of the same composition Amoxicillin and Clavulanic acid supplied by the same company for the same formulation of the same dose and strength.
• 15 companies produce each two different brands of Glimepiride + Metformin (Tablet, 500 mg).
• Four companies market Rosuvastatin (Tablet, 10 mg), with three different brands of the same formulation.¹

Thus, in India’s pharma market, product differentiation is introduced through brand differentiation, even though they are ostensibly homogeneous commodities and functionally interchangeable.

FDCs – A tool to play with permutations and combinations

This is another area where brand names play a very important role. This provision allows Indian marketing companies to play with all possible permutations and combinations of medicines. To explain it using a common example, a single drug Dicyclomine is combined with various other drugs, and all combinations are permitted for sale. For instance:

• Dicyclomine + Paracetamol
• Dicyclomine + Paracetamol + Diclofenac
• Dicyclomine + Paracetamol + Domperidone
• Dicyclomine + Paracetamol + Clinidium + Dimethicone
• Dicyclomine + Chlordiazepoxide + Clinidium
• Dicyclomine + Mefenamic acid + Dimethylpolysiloxane
• Dicyclomine + Nimesulide

This results in more than 500 brands of FDCs under Cough preparations and 500 under Vitamin combinations.

Total number of brands for certain groups of FDCs during 2011-2012

• NSAIDs: 124 FDCs with 2739 brands
• Metformin combined with other medicines: 25 FDCs with 536 brands
• Anti-depressants / Benzodiazepines: 25 FDCs with 301 brands
• Anti-Psychotics: 10 FDCs with 211 brands

Current situation – Regulation of the Indian pharma industry

There is still lax coordination between Central-State Drug regulation and a near lack of total coordination between Inter-State Drug Authorities. There is no central database and monitoring of the award of brand names. This has been pointed out by the 59^th Parliamentary Committee Report as well. This resulted in identical brands being licensed in different states containing different drugs. For example: ²

• Brand Lona was awarded for low sodium salt in one state and the same brand name Lona was awarded for Clonazepam in another state.²
• The same brand name AZ was awarded to three different contents – Azithromycin, Albendazole, and Alprazolam.
• Similarly, the same brand name Medzole was licensed for four different drugs – Metronidazole oral suspension, Itraconazole capsule, Pantoprazole injection 40 mg, and Midazolam injection.

Option to use the brand name of banned FDC

There is also the option to use the same old banned brand name for a new drug combination. For example, after the ban on the use of Dextropropoxyphene, the same trade name “Proxyvon,” which was awarded to the banned combination of Dextropropoxyphene and Paracetamol, is being allowed for a changed combination where Tramadol is replaced and combined with Paracetamol.

Before 2005, the industry was free to act as per its will and wish, as pharmacovigilance and post-marketing surveillance were not in force.

Before 2005, until 2016 when CDSCO came into the picture, many states had issued licenses to firms for the manufacture of FDCs without conducting any studies or counterchecks. In 2014, a Committee was constituted by the Government of India to study the issue of FDCs, both new and existing. In March 2016, based on its recommendations, 344 FDCs were immediately banned as being unsafe for use. However, in December 2016, the Delhi High Court put a stay on the ban, citing technical reasons. The industry pleaded in court that these FDCs had been used for many decades without any complaints from doctors or consumers on record. It is worth noting that it was the industry’s duty to keep records of all adverse drug reactions through proper post-marketing surveillance. In January 2017, the Government of India appealed to the Supreme Court of India against the Delhi High Court verdict. However, as of 2023, the issue is still pending in the court and is under active consideration by the Supreme Court. Meanwhile, most of these FDCs are still being marketed by the industry under the pretext of the court stay.

Paradox of generic medicines use in India

Following is the only reply received by one of the consumers from CDSCO on an RTI where the definition of Generic Medicine was asked.

Prices of brands are paradoxically high

Pharma contributes 43.2 per cent to the total out-of-pocket expenditure (OOPE) on health in India. This makes it the single largest contributor to OOPE, which accounts for an estimated 62.7 per cent of total health spending in the country. Thus, prices of pharma have a significant bearing on access to healthcare. While around only 17.7 per cent of the pharma market in India (in terms of value) is under price regulation, competition is expected to be the key source of price discipline for the rest of the market. However, unfortunately, that’s not the reality.

There is a significant price difference between brands of different companies for the same FDC. For example:

• The top-selling amoxicillin + clavulanic acid (Tablet, 500/125 mg) is sold by 217 companies under 292 brands, with substantial price variation, ranging from Rs. 40 to Rs. 336 for a pack of six tablets.
• Mirror brands & Price difference – One company that manufactures amoxicillin + clavulanic acid (500/125 mg, tablet) sells two brands at Rs. 18.27 and Rs. 73.17, resulting in a price variation of 120 per cent. The prices of glimepiride + metformin charged by a company for its two brands were Rs. 10 and Rs. 60 per pack of 10. Moreover, the industry is allowed to raise the price of branded medicines by 10 per cent each year.

Price difference between branded generics in private retail market and pure generics in public procurement market

The price variation between pure generics in public procurement and branded generics in the retail market across 54 molecules ranged from eight per cent to 190 per cent. In the case of 45 molecules, it is more than 100 per cent. The following table shows prices quoted in public procurement and the price charged in the private market:

• Atorvastatin (10 mg), Rs. 0.21 – Rs. 5.1 – 184 per cent
• Zinc tablet (10 mg), Rs- 0.19 – Rs. 3 per tablet – 180 per cent
• Ampicillin (500 mg) injection, Rs. 4.80 – Rs. 8 / vial (In case of 19 molecules, it is in the range of 50–100 per cent).

Contrary relationship in quality and names of medicines

From the above, it should be clear that with all the options available to the industry, brand names of generic drugs can hardly signal quality. Several firms that market their brands often get their products manufactured through third-party or contract manufacturing at the cheapest rate and are allowed to sell them at the highest price simply by attaching a brand name. Most of the time, the same third-party manufacturer makes the same medicine for multiple pharma companies. This flexibility of outsourcing manufacturing is also used as a loophole in the law and as a scapegoat. When a drug is found to be substandard, the third-party manufacturer is prosecuted under the law, and not the marketing company. Due to this, the big company escapes penalties by shifting the blame to another third-party manufacturer while continuing to enjoy its standard-quality brand status, even though it has lost it. Paradoxically, the trend of mirror brands being marketed by the same company at different prices runs counter to the proclaimed brand name-quality correlation.

Quality of generic medicines in the international market

The particular generic or brand medicine can have three different quality equivalents, namely:

1. When it is merely having the same chemical, it is called a “chemical equivalent.” This generic/brand may not have the same efficacy as the original molecule, as many chemicals show different isomers, of which only a few have efficacy. For example, Omeprazole and Rifampicin.
2. Bio-Equivalent: To exhibit its effect at the targeted organ, the medicine has to reach the organ through blood, where it is absorbed from the gastrointestinal tract after being taken orally. Generics/brands that have reached at least 80% of their concentration in the blood are called Bio-Equivalent.
3. The generic/brand medicine that has the same onset and duration of action when compared with the original drug is termed Therapeutic Equivalent. In developed countries like the US, all these equivalents of marketed generics are displayed on the US FDA website, called the “Orange Book.”

US FDA – Orange Book

The Orange Book is an online list of Generic Equivalents available in the US. It’s a coding system introduced since the 1980s, where all generic medicines available in the US are displayed with the exact composition and names of all generic manufacturers. Ratings include:

• Rating A: Awarded to generic drug products that the FDA considers therapeutically equivalent.
• Rating AB: Awarded to generic products that are bioequivalent and are therefore considered therapeutically equivalent.
• Rating B Products: Awarded to generic products with actual or potential bioequivalence problems that have not been resolved.
• Rating BX: Awarded to generic products presumed to be therapeutically non-equivalent.

This online information helps practitioners identify a product’s equivalence for substitution with the original product. The Orange Book data on generics are updated every month.

Failure of government’s mantra to reduce prices and make medicines affordable

The Indian government puts a price tag on essential and life-saving medicines selected under the National List of Essential Medicines, published by the National Pharmaceutical Pricing Authority (NPPI). However, this policy has a dual impact on both the availability and affordability of essential medicines. Big companies find new ways to avoid this price war by introducing “me-too drugs,” different salts, or using FDCs. They may also suddenly stop manufacturing these low-cost, life-saving medicines and concentrate only on high-margin products. This has resulted in the non-availability of these life-saving medicines from reputable firms, leading to constant shortages of medicines like Injection Sodium Bicarbonate, Adrenaline Injection, Aminophylline Injection, Atropine, Injection CPM, Injection Calcium Gluconate, Injection Etiphylline + Theophylline, Injection Dexamethasone, Injection Digoxin, Injection Hydrocortisone, and more.

Where are we now?

This mismanagement and lousy policies have resulted in the Indian market being flooded with medicines containing various generics and various brand equivalents, all with a wide range of safety options, quality standards, and prices. As a result, there are around 200,000 different products:

• Having various standards of manufacturing
• Having various types of licenses
• Manufactured by around 10,000 small units for about 300 large marketing units on a third-party basis
• With 10 to 100 different generic equivalents for each patented medicine available, out of which a minimum of 10 to 15 are branded equivalents
• With prices ranging from the lowest costing generic at say Rs. 0.10 per tablet to the highest-priced branded generic at Rs. 2.00 per tablet (a 100 times difference in prices).

Actions needed at the national level

The recent incident in Gambia should be a wake-up call for Indian pharma companies. It is now necessary to improve the drug quality policy and raise the bar of quality standards to the global level. Some gaps need immediate attention:

1. Global harmonisation of quality: Make it mandatory for all drug manufacturers to provide, manufacture, and import-export medicines of the same highest quality worldwide.
2. Stop issuing licenses for companies engaged only in marketing medicines and abolish the “Outsourcing of Manufacturing” by big companies as well. Or enact a law holding marketing companies equally responsible for prosecution and conviction along with third-party manufacturers for the supply of substandard medicines under the Drugs and Cosmetics Act.
3. Strengthen State Drug Control Organisations with proper funds and competent and trained personnel for effective drug regulation. Make “up-to-date training” mandatory for drug controllers to keep them updated with modern technology.
4. Increase penalties for the sale and manufacture of spurious drugs causing grievous harm or death, from life imprisonment to the death penalty. Make offenses related to the manufacturing and sale of spurious drugs non-bailable.
5. Ensure that prosecution under the Drugs and Cosmetics Act is immediately followed by filing an FIR by the police department. Provide social compensation in the form of economic help to families affected by the consumption of substandard medicine.

Immediate actions to address the chaos of branded vs. generic medicines

To immediately check the proliferation of branded medicines, consider the following:

1. Stop issuing licenses to firms that are purely engaged in marketing. Issue licenses only to those with at least one “OWN manufacturing unit.”
2. Issue brands only to those generic medicines that are manufactured under an “OWN license” and not on a third-party basis.
3. Now with AI based technology it should be easy to have a central database of all brands at one site. This will put the use of same brand names at zero level.

These immediate solutions will help regulators address 80 per cent of the current problems created by the proliferation of brands versus generic medicines.

In summary, before implementing the compulsory order for doctors to use “Only generic names” while prescribing medicines, it is essential to have the pharma regulatory system in proper order.

saravdekarsuresh@gmail.com

References

• 1) MARKET STUDY ON THE PHARMACEUTICAL SECTOR IN INDIA-Key Findings and Observations-18-11-2021- Competition Commission of India,10th Floor, Office Block – 1, Kidwai Nagar (East), New Delhi – 110023, India

• 2) Fifty-ninth report on the functioning of the central drugs standard control organisation (CDSCO) (presented to the rajya sabha on 8th may, 2012)-(laid on the table of the lok sabha on 8th may, 2012)

The post Cracking the code – Generic vs. Brand Medicines appeared first on Express Pharma.

 According to the World Health Organisation (WHO), an estimated two billion people across the world do not have access to essential medicines for life threatening diseases like cancer, AIDS and even autoimmune diseases like Type 1 diabetes. In India, this situation is far more appalling, with an estimated 65 per cent of the population lacking access to potentially life-saving drugs and health-related expenditure constituting about 63 per cent of total out-of-pocket household expenses. In this context, it is important to improve access to essential medicines in our country by taking measures aimed at reducing the cost of drug production, introducing more cost-effective options to expensive biopharma products and improving their distribution and availability across urban and rural centres alike. 

Improving pharma access equity and health insurance coverage 

An important part of achieving Universal Health Coverage, providing access to affordable and quality-assured essential medicines has been a focal point of the Indian government since the past few decades. In a bid to resolve both physical and financial restrictions inhibiting equitable access to quality medicines, the Jan Aushadhi scheme was launched in 2008 and envisaged the setting up of dedicated Janaushadhi Kendras to provide quality generic medicines at capped prices for the general public. This scheme which was significantly revamped and renamed as the Pradhan Mantri Bhartiya Janausadhi Pariyojana (PMBJP) in 2015, now has 9000+ such centres across the country that stock around 1,800 essential drugs and 285 odd surgical items. 

To help financially weak citizens gain access to affordable healthcare, the Pradhan Mantri Jan Arogya Yojana (PMJAY) was launched in 2018, providing about 500 million Indians with a ₹5 lakh family health insurance cover that include coverage for 1,400 medical procedures as well as critical diseases like prostate cancer. However, despite these efforts, there is still a lot to be done in terms of improving all dimensions of access to medicines, especially the affordability of critical drugs used to treat serious illnesses and maintaining international-level quality standards while exploring more cost-effective manufacturing and distribution techniques. 

Leveraging advanced research and technologies to make critical drugs more affordable

Although India is the world’s largest supplier of generic medicines, earning it the sobriquet of being the ‘Pharmacy of the World’, there is a clear need to invest in technologies of the future, pursue fully integrated drug development and innovate disruptive manufacturing processes that can slash the overall cost of production. 

Take for example expensive biopharma products like innovator biologics, which are complex medicines produced using living cells or organisms that are used for precise and targeted treatment of cancer, autoimmune diseases, metabolic disorders and even hormone deficiencies. By developing good manufacturing practice (GMP) plants with continuous manufacturing processes, domestic biotech players can produce quality biologics at lower costs, which in turn can translate into lower medical expenses for lakhs of patients in the country. In fact, this can lay the foundation for a disruptive and affordable manufacturing platform that can bring to market innovative immunotherapy treatments for chronic or life-threatening ailments. Considering that the capitalised R&D cost for launching a new biopharma product has been doubling every ten years, India could even establish itself as a global biopharmaceutical hub by virtue of introducing more efficient process development methods that are eventually scaled up and applied in the manufacturing of such critical biopharma products. 

Reinventing biosimilars as more worthy alternatives

With the passing of the Biologics Price Competition and Innovation (BPCI) Act of 2009, the US Food and Drug Administration (FDA) created a shorter approval path for biological products that are highly similar to already approved biologics. Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality. However, due to significantly lower spends on R&D and shorter lead times from development to launch stage, these biosimilars are proving to be more affordable when treating maladies such as rheumatoid arthritis, osteoporosis, colorectal cancer, Type II diabetes and even bone tumours.

Biosimilars possess a significant advantage over innovator drugs as they can transform into superior products by utilising manufacturing technologies that offer inherent reproducibility and increased cost benefits. This enables them to establish themselves as upgraded alternatives. Indian pharma players could play a key role in positioning biosimilars as superior products to costly biologics. What’s more, with many key biologics scheduled to lose patent protection in this decade, Indian pharmaceutical companies ought to seize this opportunity and leverage innovative technologies to introduce quality and way more affordable biosimilars in the domestic as well as global markets. Not only will this precipitate into lower treatment costs and ensure equitable biopharma access for Indian patients, but could also peg Indian pharma companies to become global market leaders in the biosimilars segment and effect a major change in drug pricing standards.

The post Is India capable of ensuring equitable access to biopharmaceuticals? appeared first on Express Pharma.

ESG has been topping the pharma agenda for some time, but recently, there’s been a step change, with growing momentum.

Individual businesses are moving away from working in silos, adopting a collaborative approach, sharing insights and learnings to benefit from the whole pharma industry’s ESG credentials. Greater emphasis is also being placed on ESG in tender and investment decisions – a cause for optimism.

This new phase in pharma’s ESG journey is an opportunity for the sector to make new inroads towards more sustainable, inclusive and responsible practices. Just as ESG cannot be shouldered by one department in any business, meaningful change will be accelerated if organisations work together and exchange learnings.

Pharmanovia has long been committed to doing business responsibly. Back in 2021, we set out to formalise our approach to ESG and launched our first sustainability report last year. This included integrating our ESG strategy into our business strategy, applying greater rigor to how we measured our carbon footprint and setting science-backed stretch targets, challenging us to re-think how we do business.

One year on, our second report shares the results of novel pilot schemes and what we’ve learned so far.

Pharma must not neglect Scope 3 emissions

The pharma industry is not historically a strong performer in terms of sustainability. The sector is a bigger polluter than the automobile industry, estimated to directly generate about 52 mega tonne of CO₂ emissions. The operative word here is ‘directly’.

Indirect – Scope 3 – emissions from pharma’s value chains haven’t been factored into this figure and for a non-manufacturing company like Pharmanovia, these emissions account for a significant proportion of its carbon footprint.

To put this into context, Scope 3 emissions accounted for 99 per cent of Pharmanovia’s CO₂ emissions in 2022. Yet, a recent industry report found just 16 of the 500 pharma companies polled currently measure their entire Scope 3 emissions. Understanding your carbon footprint across the supply chain is the first step towards a more sustainable business, but many aren’t accounting for the indirect impact they are having in their measurements.

We believe it’s our responsibility to hold our partners to the high standards we expect of ourselves and to choose to work with responsible, value-aligned third parties. Continual monitoring of third-party progress and commitment to ESG initiatives, must form a significant pillar of pharma’s ESG strategy. Holding partners accountable for how they conduct business and helping those falling behind to develop plans for improvement, offers pharma an opportunity to influence meaningful change.

Innovation can lead to carbon, waste and cost reduction benefits

After measuring our Scope 3 emissions in 2021, we recognised that global transportation was having one of the biggest impacts on our carbon footprint, so we challenged ourselves with mapping out a pathway to manage these emissions.

Last year, we launched a pilot programme to understand the impact transitioning from air to sea freight could have, focussing on our Spain-to-Australia freight route.

The pilot successfully avoided an estimated 470,000kg in potential CO₂ emissions in 2022, equating to an 18 per cent reduction in our Scope 3 upstream transport emissions.

The innovative pilot not only delivered benefits in terms of carbon, but in waste and cost reduction, too.

Air freight is reportedly responsible for up to 80 per cent of all temperature excursions in the pharma industry, requiring medicines to be destroyed. During our pilot, no sea shipments experienced temperature excursions, thus reducing waste.

The transition also presented the opportunity for us to re-evaluate the expiry period of our medicines. Following testing, we were able to successfully increase the shelf-life of some products, once again mitigating and reducing waste, all while continuing to serve patients around the world.

We have now made a landmark pledge to divert 40 per cent of our air shipments to sea in 2023, and 75 per cent by the end of 2028.

Employees have the power to drive change

Sustainability shouldn’t be something we just talk about but something that we do. According to the World Economic Forum employees play a vital role as advocates and enablers of ESG strategies.

To engage our people with our strategy, we wrote ESG goals into employees’annual performance objectives, with everyone across our global officestied to ESG targets. This was an important move to encourage proactivity and ensure a sustainable lens was applied to our day-to-day work.  We also have four employee groups designed to drive new initiatives in support of our ESG goals.

We can confidently say that we have seen first-hand how empowering employees can lead to great strides. Employees achieved a 98 per cent completion rate of compliance training, which included ESG modules.

It’s an approach that we will continue to adopt with new targets set for all employees each year.

The climate crisis is often badged as the challenge of our time and Pharmanovia has made rising to this challenge and sharing learnings its mission. The health of the planet is intrinsically linked to the health of its citizens, which is why baking ESG into every layer of our business is so important to us. 

The strategies we have piloted have yielded great success, defining novel paths towards a more sustainable sector. This is not box ticking exercise though and there’s far more to be done. In the spirit of striving for continual improvement, we now look forward to new ambitious targets and working with our partners to deliver a healthier planet.

The post Three lessons from Pharmanovia’s ESG Report appeared first on Express Pharma.

Diversity, equity and inclusion (DE&I) are fundamental principles that drive positive change and progress in various aspects of society. These principles recognise and celebrate the unique characteristics and experiences of individuals, ensuring fair representation, equal access, and opportunities for all.

In the context of clinical research, diversity refers to the inclusion of individuals from various demographic backgrounds, including race, ethnicity, gender, age, socioeconomic status, and more.

Recognition and inclusivity of transgender individuals

Inclusivity entails creating an environment that respects and embraces differences, fostering a sense of belonging and ensuring that all individuals have a voice and are heard. Equity goes beyond equality by addressing systemic barriers and providing fair and just opportunities, resources, and outcomes to individuals regardless of their backgrounds. By embracing diversity, equity and inclusivity, we promote a more comprehensive and accurate understanding of health and disease, improve healthcare outcomes, and advance towards a more equitable and just society for all.

The US has 16 lakh transgender people and in the UK, around 2.62 lakhs.¹ There are 4.8 lakh transgender people in India, according to the 2011 census, but campaigners believe the true number may be closer to 15 lakhs. The National Portal for Transgender Persons, established in 2020 by the Department of Social Justice & Empowerment, has provided much-needed relief to the transgender community to receive the necessary acknowledgement in India.^{1, 2}

Health for all, including the transgender community

Diversity, equity and inclusion in clinical trials are not just desirable but essential for several reasons. Firstly, every individual, regardless of their gender identity, deserves equal access to healthcare and the opportunity to participate in research that directly impacts their well-being. By including diverse populations in clinical trials, we can ensure that the benefits of medical advancements apply to everyone, including transgender individuals.

Secondly, excluding transgender individuals from clinical trials hinders our understanding of their specific healthcare needs. Transgender individuals often face unique health challenges related to hormone therapy, surgical interventions, mental health, and more. Without their representation in research studies, we miss valuable insights into effective treatments and interventions tailored to their needs. Comprehensive data from diverse populations is crucial for evidence-based medical practice and the development of inclusive healthcare policies.

Thirdly, promoting diversity, equity and inclusion in clinical research is a matter of social justice and human rights. Transgender individuals have historically been marginalised and faced discrimination within the healthcare system. By actively addressing the underrepresentation of transgender individuals in clinical trials, we can challenge and overcome systemic biases, promoting a more just and equitable society.

Addressing challenges in DE&I

To achieve diversity and inclusivity in clinical trials, it is essential to raise awareness and advocate for increased education among healthcare professionals. By enhancing their understanding of the healthcare needs of transgender individuals, we empower healthcare providers to deliver more competent and sensitive care. This can be achieved through incorporating transgender-specific healthcare education into medical school curricula, offering ongoing training opportunities, and fostering a culture of respect and inclusivity within healthcare organisations.

However, several roadblocks hinder the participation of transgender people in clinical trials. One significant challenge is the burden placed on transgender individuals due to numerous medical appointments. Hormone therapy, surgeries, and regular monitoring of health create a time-consuming and costly commitment, making it difficult for them to participate in lengthy clinical trials that require frequent visits. Addressing this challenge requires innovative trial designs, such as remote monitoring or flexible scheduling options, to minimise the burden on participants.

Parexel’s report on gender identity report, Beyond the Binary: Navigating Gender Diversity in Clinical Research, provides valuable insights into creating more equitable clinical trials for transgender and nonbinary patients. The report identifies five roadblocks to participation: lack of awareness and understanding, logistical challenges, mistrust and safety concerns, limited recruitment strategies, and limited data collection and reporting. It also offers eight solutions, including raising awareness and education, streamlining logistics, building trust and ensuring safety, implementing diverse recruitment strategies, and improving data collection and reporting.

The way forward – towards true DE&I

As the world recognises the urgency to foster inclusivity and promote equitable clinical trials, we must work collaboratively with healthcare providers, researchers, advocacy groups, and the transgender community to implement these solutions. By addressing roadblocks and striving for inclusivity, we can create clinical trials that reflect the diversity of our population, generate more robust evidence, and ultimately improve healthcare outcomes for all individuals, including transgender and nonbinary patients.

References

1.    https://www.parexel.com/insights/discussions-diversity/gender-identity-in-clinical-trials

2.    They thought I was a curse’: The struggles of India’s trans community. Accessed from: https://www.opendemocracy.net/en/5050/india-transgender-discrimination-health-gender-affirmation-surgery/

3.    The Transgender And Unemployment In India. Accessed from: https://www.outlookindia.com/national/transgender-and-unemployment-in-india-news-182617

4.    Overcoming obstacles in trans and nonbinary participation in clinical trials. Accessed from: https://www.clinicaltrialsarena.com/news/transgender-clinical-trials/

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Pegged as one of India’s fastest growing pharma companies, JB Pharma’s recently released fourth quarter and year ended March 31, 2023 results continue to beat market growth rates.

As per IQVIA MAT March 2023 data, JB Pharma continued to be the fastest growing company amongst the Top 25 in FY23, outperforming the Indian Pharma Market (IPM), growing at 22 per cent versus 8 per cent, aided by the organic business growing at 21 per cent. India business (domestic sales) of the overall sector grew by 15 per cent for Q4 FY23, whereas JB Pharma’s domestic business grew double at 30 per cent. (See BOX: JB Pharma Business highlights: Q4 FY23 and FY23).

Will JB Pharma’s dream run continue? And what are the risks of pursuing an acquisition-driven growth strategy? As pharma promoters in the India pharma sector contemplate bringing strategic investors on board, JB Pharma’s transition strategy and steady rise up the ranks is being closely observed and could well become a success story worth emulating by its peers in the sector.

Nikhil Chopra, CEO and Wholetime Director, JB Pharma commented that this “market-beating performance” is “pivoted around their strategy to make big brands becoming bigger, and significant demand acceleration in the acquired portfolio.” He pointed out that each of their top seven brands (Rantac, Cilacar, Cilacar-T, Metrogyl, Nicardia, Azmarda and Sporlac) have ascended through the ranks. Further, Sporlac, the acquired business in probiotics and pediatric segment, is the newest entrant to IQVIA’s Top 300 brands from their portfolio.

Flashback

Till 2020, JB Pharma was like many promoter-driven pharma companies. Started in 1976 by the late JB Mody as JB Chemicals & Pharmaceuticals Laboratories (JBCPL), the company made a name for itself with brands like Metrogyl (1977), Nicardia (1980), Rantac (1989), Cilacar (2007). Overseas, the company’s Doktor Mom and Rinza brands were able to tap into the Russia and CIS OT market.

Founder JB Mody carefully steered the ship through the choppy seas of evolving regulations, spiralling prices and increasing price control. Cut to July 2020, when the JBCPL founders sold controlling stakes to private equity firm Kohlberg Kravis Roberts and co (KKR).

With KKR at the helm, and a new management team headed by Chopra, the company jumped nine ranks in two years, from rank #32 in MAT 2021, to #23 in 2023. The company’s prescriptions continue to grow at a market-beating pace; with the company ending FY23 ranked #15 in the IPM.

Building blocks of a successful transition

Analysing JB Pharma’s transformation strategy post KKR acquiring majority controlling stakes in the company, Chopra highlights three major initiatives.

1. Transformation of India business by establishing a new go-to-market model, making big brands bigger.

After KKR came on board in July 2020, Chopra reveals how they took up a restructuring exercise both internally and externally. Showing its aggressive intent, the new management had initiated a series of measures to transform the entire business.

He narrates how the management put forth an accelerated growth strategy where they would not only build upon core competencies but also leverage strengths to enter into new therapeutic areas. Backed by over 5,000 employees including a 2,500-strong sales force, Chopra says JB Pharma has put in place a new ‘go-to-market’ model, where they focus on life-cycle management for big brands and evaluate new growth opportunities to further enhance productivity.

Giving more granular detail, Chopra explains how their focus on making “big brands … bigger was substantiated by launching line extensions of existing franchises and focussing on sales force excellence and automation. Furthermore, expansion into tier 4 and rural towns helped India business in increasing the reach and availability for current brands.”

Chopra analyses how one of the pillars of strategy has been acquisition-led growth. JB Pharma completed four major acquisitions (brands from Sanzyme, Azmarda, Razel franchise and paediatric portfolio from Dr Reddy’s Laboratories), thus foraying into the fast-growing probiotics, paediatric and the niche of the heart failure segment. These portfolios offer deep geographic and distribution synergies along with prescriber overlap. In six months, Sporlac now is among the top three brands in the probiotic segment, providing significant opportunities to expand through line extensions.

2. A ‘beyond the pill’ marketing approach

Chopra revealed that he emphasised a ‘beyond the pill’ marketing approach in the Indian pharma industry, which involved organic and inorganic initiatives to enhance patient awareness, education, diagnosis and adherence through various ‘phygital’ initiatives.

Other areas of expertise include digitalisation of the pharma field force and engagement with doctors, nurturing talent and creating cross-functional collaborations and propagating technology in improving healthcare access and awareness.

He stresses that for JB Pharma, the domestic formulations business remains a key focus area and it has been consistently growing at better than industry growth rate over the last several years.

He also refers to another trend in the IPM. While India has historically been a market dominated by acute therapies, the trend has been shifting to a larger contribution from chronic drugs in the consumption base. As per IQVIA IMS data, the share of chronic therapies in the IPM has expanded from 31 per cent to 36 per cent in the period between FY13 and FY21. This is in line with the trend in several global economies that have seen a larger incidence of lifestyle diseases on the back of improved diagnoses and better compliance by patients.

JB Pharma’s international business contributes around 50 per cent of the total revenue, comprises three segments: export formulations, API and contract manufacturing. The business grew by 16 per cent to Rs 382 crores in Q4 FY23 versus Rs 330 crores in Q4 FY22. The international formulations business was at Rs 255 crores in Q4 Fy23 versus Rs 218 crores in Q4 FY22 recording growth of 17 per cent.

JB Pharma operates distinct operating models across multiple international businesses with a direct presence in Russia and South Africa as well as distributor relationships in the US and a large number of markets across Asia, Africa and Latin America. According to Chopra, JB Pharma has a leading global position in the contract manufacturing market driven by marquee client relationships.

3. Development beyond financial metrics to a new cultural identity

JB Pharma also recently marked one year of a new corporate identity as JB, centred on being “simple, reliable and agile” while building on the strong foundation of “integrity, trust and reliability” nurtured over the past 45 odd years.

Explaining the vision behind the new identity, Chopra said, “The company offerings and capabilities are becoming more diverse to cater to the evolving needs of customers, manufacturing processes are becoming more robust, and lean, and our vision of looking at the healthcare industry is becoming more progressive globally.

We are adapting ourselves to become more responsive to the needs of the healthcare world. In sync with the evolving healthcare industry and the changing need of customers, JB has re-visioned the cause of spreading good health in India. JB aims to support healthcare providers and enrich patients’ lives in innovative new ways while remaining committed to its core values of integrity, trust and reliability built over 45 years.”

This was inculcated in terms of initiatives within the organisation that made employees and departments agile and cultivated a cross-collaborative culture. As CEO, Chopra reportedly played an active role in developing this and led leadership culture-building exercises such as OneJBWay (a leadership transformational programme). Furthermore, the same OneJBWay culture is cascaded to the second in line of leaders (N-2) through a forward-looking leadership training and excellence programme called LEAP.

4. Publishing inaugural sustainability (ESG) report

Chopra explains how the ESG report was prepared following the international reporting standards framework, the Global Reporting Initiative (GRI) as its Core Standard, and linkages with the Sustainable Development Goals (SDGs).

As per Chopra, from FY 2020 to FY 2022, the organisation has reduced energy consumption by 9.2 per cent and augmented green energy through solar power. Additionally, its Scope 1 and Scope 2 emissions have reduced by 14.6 per cent and 10.7 per cent during the same period. During the reporting period, waste sent for co-processing stood at 757.65 MT. All sites are Zero Liquid Discharge.

JB Pharma’s strategy for FY24 and beyond

Looking ahead, Chopra is emphatic that “our biggest bet is India as 50 per cent of our revenue comes from here. We will continue to leverage opportunities that lead us to organic growth and diversify into newer categories that can be in generic formulations, wellness etc. We will also be looking for acquisition opportunities, which are a strategic fit and assure returns within the payback period. The other strategy is to grow our big brands such as Cilacar, Cilacar-T, Rantac, Metrogyl, Nicardia and Azmarda.”

Spelling out the goals for the next few years, Chopra says that they plan on accelerating towards their 50th year in 2025. “In the next three years, we want to increase our market share by being among the top 20 companies in the IPM market. Under the new strategy, our major focus is to strengthen our core therapy segments i.e., hypertension, respiratory, gastroenterology, nephrology, cardiology, dentistry, and paediatrics.

If FY21 was about realigning the structure and portfolio to ensure sustainable growth and focussing strongly on the lifecycle management of their flagship brands, the next priority is to scale up R&D and business development initiatives towards building a progressive portfolio for the US, Russia, South Africa, and API. Chopra says that they will focus on consolidating their business areas through a deeper presence in existing geographies and this will be aided by multiple new launches over the next two to three years.

Building a cohesive entity

With four brand acquisitions in 15 months and close to 1500+ appointments, across businesses and geographies in the last year, JB Pharma’s new identity is evidently an attempt to ensure common brand values across a rapidly expanding workforce.

Chopra says that each brand acquisition came with a sales force from different companies that was relevant to their existing salesforce team and gave geographical synergies. This added almost 500-600 people across divisions of heart failure, hypertension, wellness, respiratory etc.

And Chopra reveals that there could be more acquisitions, as the company will continue to evaluate (further brand acquisition) opportunities and see if there are assets available within the space of paediatrics, cardiology, metabolics, respiratory, and anti-infectives.

It will be interesting to observe how JB Pharma is able to assimilate the ‘acquired’ sales force into a cohesive entity. Talent retention will be a key component, given the cutthroat competition in the IPM. According to Chopra, the company’s continuous focus/endeavours on talent retention led to 200+ promotions in FY23. Most pharma companies struggle to increase productivity per sales professional, leading to high attrition rates.

Chopra reiterates, “Our current philosophy has a strong foundation of the legacy brand on which the new identity has been built and carried forward. This is highlighted best in three aspects – our people, our results and our products. We are the fastest growing company with fast-tracked growth for careers as well. This is supplemented by strong learning and development programmes across levels and locations. Last but not the least, a healthy work-life balance is critical to increased productivity which is catered to by our wellness initiatives. We are also in the process of introducing a competency matrix which would aid in talent retention.”

JB Pharma’s transition from a promoter-driven to a private equity-led entity is part of a larger trend not just in India, but across the globe. Balancing the legacy of the founders with the management strategies of the strategic investors will be crucial in the quarters ahead.

viveka.r@expressindia.com

viveka.roy3@gmail.com

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The pharma industry is one of the critical pillars of India’s economy, and supply chain is what gives it enduring strength. For the longest time, however, the pharma supply chain was unorganised. This is changing now, with the entry of big players and retail giants. We are also seeing a shift away from the old ways when patients used to go to pharmacists to pick up the medicines they needed. Today the pharma, healthcare, and retail industries offer not just products, but personalised experiences and value-added services to patients. Products are delivered to people’s doorsteps in record time, that too with discounts and offers.

India is the world’s third largest producer of pharma products and has earned the sobriquet of “the pharmacy to the world”. Indian pharma companies have a substantial share in the prescription market in the US and the EU. India also has the largest number of FDA-approved plants outside the US.

To continue driving growth for the industry, we need modern, smart supply chains that are compliant with both domestic and international regulations; follow robust standard operating procedures; have multimodal capabilities across air, land, and water; provide end-to-end visibility and control; and use the latest technologies for competitive advantage. Let us examine some of the recent developments and emerging trends on the policy, consumer, and technology fronts that are shaping the evolution of India’s pharma supply chain.

Policy-aided modernisation and growth
The supply chain in post-Covid times is being shaped, in part, by government policies. In September 2022, the Central Government announced the National Logistics Policy with the objective of lowering the cost of logistics, increasing the competitiveness of Indian products in domestic and international markets, and improving the efficiency of industries. India’s pharma MSMEs will benefit from the reduction in logistics costs. The establishment of multi-modal logistics parks, as proposed in the policy, will improve last-mile connectivity, and strengthen the cold storage and warehousing infrastructure across the country. It will also allow for inventory buffers, thus lessening our dependence on other countries for raw materials.

In the pharma supply chain, products are usually sent to C&F agents, then to city-level distributors, and ultimately to retailers. Since much of this happens at a local level, it can cause compliance issues, especially when it concerns medicines that need to be transported and stored at specific temperatures. This is because, in India, temperatures can vary widely across states, and even within cities in the same state. The newly proposed storage and warehousing policies will guide the ongoing efforts of pharma and logistics companies in addressing such issues by increasing the accessibility of the cold chain infrastructure and enhancing the connectivity to the storage areas through multimodal connectivity.

Building robust cold chain and reverse logistics capabilities
Cold chain is one of the toughest aspects of logistics to get right, and the demand for it is on the rise. Pharma and healthcare companies often ship products like vaccines, blood products, and medicines, which need to be maintained at certain temperatures to preserve their potency and validity. This can be achieved through temperature-controlled warehousing and transportation, with IoT sensors to continuously monitor the temperature. Furthermore, cold chain systems must have inbuilt protocols for mitigating risk and loss, and strong capabilities for dealing with contingencies.

Reverse logistics capability is yet another crucial aspect of pharma supply chain. There could be times when certain products need to be withdrawn from the market. This entails picking up the product from every nook and corner of the country and bringing it to the company’s warehouses or to their country of origin. There’s a need for more investments in setting up dedicated centres that perform quality checks, re-labelling, and dispatch of the returned products to the warehouses. Technology will help in developing a robust control environment to prevent fraud and tampering in both forward and reverse logistics.

The role of Blockchain
Spurious drugs are a serious issue across the world, but a technology-enabled, transparent supply chain can help in addressing it. In Africa, improvements in pharma supply chain have reduced the prevalence of spurious and failed drugs from almost 45 per cent to less than 10 per cent in the past 10-15 years.

Supply chain visibility, speed and coordination are critical to the safe and timely delivery of pharma products, and Blockchain technology can be of great help in several areas. These include monitoring the cold chain; identifying contamination of high-value, temperature-sensitive products; ensuring the authenticity of products; improving time and cost efficiencies; addressing regulatory requirements for drug tracking, and more. Blockchain can help in accurately recording price, date, location, quality, certification, and other relevant information. This improves supply chain transparency and traceability and reduces administrative costs. Blockchain can help pharma companies build trust and optimise the value chain through secure and tamper-evident data-sharing; product provenance; and digital asset tracking. Blockchain technology can give a clear picture of every capsule, every drop of a product from the manufacturer to the consumer, and nobody can manipulate the data.

Predictive supply chain with Big Data, AI, and ML
Pharma businesses that invest in Big Data Analytics, or work with logistics partners who do so, gain a great competitive advantage, as they can make more informed decisions, optimise capacity utilisation, reduce risk, and improve customer experiences. Dynamic, real-time route optimisation through the correlation of multiple data streams (such as shipments, weather, and traffic) can enable more efficient scheduling of consignments, optimisation of load sequences, and accurately predict the time of arrival. Smarter forecasting of demand, capacity, and labour can significantly optimise planning and resource utilisation and reduce supply chain costs. Big Data can be used to mitigate risks by detecting, evaluating, and providing alerts on potential disruptions caused by unexpected events, man-made or natural. This can be further enhanced with the integration of data from IoT devices.

Big Data, together with Artificial Intelligence (AI) and Machine Learning (ML), can also help pharma companies predict prescription trends and align their operations accordingly, well in advance. Geography-based market trends, customer behaviours, and healthcare trends can be used to predict orders. For instance, Rajasthan might have higher prevalence of a different set of illnesses as compared to Karnataka. The demand for medicines will accordingly differ. By studying the demand data, AI will be able to predict the prescription trends, and enable pharma companies and retailers to be ready with adequate quantities of the required products at the distribution centres that are closest to the most likely customers. This can help pharma retailers to meet heavy demand and offer quick home deliveries.

With pharma industry accelerating its digital transformation journey, the supply chain services providers have also increased their focus on driving innovations backed by data to strengthen the pharma and medical logistics. For instance, DP World’s production management and business intelligence tools provide enhanced visibility and control across the supply chain, thereby supporting optimum decision making. Furthermore, company’s suite of digital technologies is helping our customers identify bottlenecks in their supply chains and smooth the flow of medical supplies across borders.

Looking ahead
The era of the metaverse is dawning, and although it’s still early days, we can expect the metaverse to find a wide range of use cases that enable pharma companies to improve their experiential offerings. The metaverse will also play a vital role in applications such as simulating terminal operations; carrying out container and vessel inspections; conducting immersive, online safety trainings; and creating Digital Twins where a virtual representation of real-world processes is created, which can help in addressing industrial and supply chain challenges and achieving substantial time and cost savings.

Metaverse can help a single operator monitor terminals from different parts of the world in real time through virtual reality. It can also enable pharma companies to virtually check out the facilities and capabilities of prospective logistics partners. From a user benefit standpoint, Metaverse can be used to demonstrate the correct way of administering a certain medicine.

In coming years, we could see specialisations emerging within the pharma supply chain. Clinical trials, for instance, require a specialised supply chain because the samples are highly sensitive and need careful management and handling.

Meanwhile, as the costs and complexities of healthcare and pharma logistics continue to rise, pharma companies need logistics partners who can mitigate any adverse impacts on their business and on patients. The ability to leverage relationships, network, experience and skills is crucial to ensure that access to quality healthcare remains equitable across the globe.

Partnering with logistics providers can yield significant benefits for pharma companies on both the business and the consumer health fronts. With the health of millions of humans at stake, there is no room for compromise or laxity.

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The idea of green chemistry was initially developed as a response to the Pollution Prevention Act of 1990, which declared that US national policy should eliminate pollution by improved design including cost-effective changes in products, processes, use of raw materials, and recycling instead of treatment and disposal.

The 12 Principles of Green Chemistry were published in 1998, providing the new field with a clear set of guidelines for further development.

In the last 10 years, national and international networks have proliferated, special issues devoted to green chemistry have appeared in major journals, and green chemistry concepts have continued to gain traction. A clear sign of this was provided by the citation for the 2005 Nobel Prize for Chemistry awarded to Chauvin, Grubbs, and Schrock, which commended their work as “a great step forward for green chemistry”.

In recent years, pharma industry has been exploring the potential of green chemistry in drug manufacturing. This sector is responsible for producing life-saving drugs and has the potential to make a significant impact on global sustainability efforts by adopting green chemistry practices. Thus, implementing green chemistry in pharma manufacturing can reduce waste and pollution, improve efficiency, and promote sustainability and social responsibility.

Furthermore, recent developments in adopting green catalysts, enzymes, have provided breakthrough advantages over traditional chemistry by being able to selectively catalyse the reaction, save costs and time as well as reducing impurities and waste, hazardous byproducts.

It is noteworthy that the Nobel prize in chemistry in 2018 was given to enzyme engineering highlighting the importance of its role in reducing pollution and environmental impact.

Hence, as the demand for sustainable pharma continues to grow, green chemistry and more specifically, enzymes will play an increasingly important role in the future of pharma manufacturing.

Here’s how green chemistry will transform the future of pharma manufacturing:

Reducing waste and pollution: Pharma manufacturing is energy- and resource-intensive, often resulting in large amounts of waste and pollution. Traditional methods of drug synthesis typically rely on hazardous chemicals, which can pose a significant risk to both human health and the environment. Thus, green chemistry offers an alternative approach, utilising safer and more sustainable materials and processes. Using enzymes as catalysts instead of typical chemical catalysts is one example of a green chemistry method in pharma manufacturing. Enzymes are biodegradable and pose minimal environmental impact, while increasing drug production selectivity and efficiency. Hence, green chemistry can dramatically minimise the environmental effect of pharma manufacturing by lowering the usage of hazardous chemicals and minimising waste.

Improving efficiency and reducing costs: Green chemistry can enhance the effectiveness of pharmaceutical manufacturing processes and decrease waste as well as pollution. It can simplify drug synthesis and reduce production time and cost by utilising new technologies and innovative methods. Furthermore, continuous flow chemistry is an example of a green chemistry technology that enables faster and more efficient drug manufacturing. It uses small reactors to conduct continuous reactions, resulting in shorter reaction times, higher yields, and less waste. Thus, green chemistry can help make drugs more accessible and affordable for patients by lowering the time and cost of drug manufacturing.

Promoting sustainability and social responsibility: Green chemistry in pharma manufacturing benefits not only the environment and industry, but can also encourage social responsibility and sustainability. In the modern-day world, as consumers are becoming more aware of the environmental impact of products, they are seeking more environmentally friendly alternatives. Thus, by adopting green chemistry practices, pharma companies can demonstrate their commitment to sustainability and responsible manufacturing. Furthermore, green chemistry can aid in promoting sustainability throughout the supply chain. Therefore, pharma businesses can encourage suppliers to adopt more sustainable practices by employing more sustainable materials and minimising waste. This has the potential to spread positivity throughout the sector, boosting sustainability and social responsibility.

Challenges and opportunities: While chemistry offers many benefits to pharma manufacturing, there are also challenges to its adoption. One significant challenge is the need for investment in new technologies and equipment. Green chemistry requires new and innovative technologies, which can require high upfront costs. However, as the demand for sustainable pharma grows, the long-term benefits of green chemistry will outweigh the initial investment.

Another challenge is the need for regulatory approval. Green chemistry practices and technologies may require regulatory approval before being implemented in pharma manufacturing. This can slow down the adoption process, but it is necessary to ensure the safety and efficacy of pharma products.

Green chemistry paves the way for sustainable pharma manufacturing!

Green chemistry represents an exciting and innovative approach to pharma manufacturing. The adoption of green chemistry practices can lead to a reduction in waste and pollution, improvements in efficiency, and promotion of sustainability and social responsibility throughout the industry. Even though there are challenges to its adoption, the long-term benefits of green chemistry outweigh the initial costs. Furthermore, as the demand for sustainable pharma continues to grow, the pharma industry can significantly impact global sustainability efforts by adopting green chemistry practices. Thus, the transformation of pharma manufacturing towards green chemistry is essential for meeting sustainability goals and improving public health by ensuring the production of safe and effective medicines.

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Launching innovative products across global markets is an effective revenue generation method for life sciences companies. Regulatory compliance and approvals being the driving factors behind any successful launch, inadequate regulatory information can trigger an increase in costs and time-to-market. The role of a comprehensive regulatory intelligence (RI) approach is paramount in the launch process.

The life sciences industry is governed by continuously evolving regulations requiring industry players to stay informed and stay compliant. Keeping up with the ever-changing regulatory landscape can be challenging for life sciences manufacturers.

Furthermore, collation of the enormous amount of information, understanding and interpreting all the regulatory updates available on the Health Authority (HA) websites, third-party databases, and adapting to the new regulations puts an additional burden on the company resources. To counter these challenges and hurdles, an increasing number of organisations prefer to rely on RI tools and services. These tools and services assist in creating a compliant strategy and execution plan thereby avoiding any mishaps throughout the product lifecycle. For over a decade now, large and enterprise companies have been investing in a dedicated RI function. Despite the integration of RI tools, solutions, or support, organisations still face difficulties in decoding the regulations and complying with them. This could partly be due to the inefficiency of existing tools to tackle end-to-end RI on a global scale.

In this digital era, information is infinite. In fact, with so much information on hand, companies struggle to segregate useful information. Not all data is relevant to the companies and there can be a significant amount of noise that regulatory professionals need to filter. The information needs to be processed effectively for regulatory compliance and even the filtered-out information can also prove to be useful, with an effective approach for RI.

Moreover, as described in Table 1, different stakeholders responsible for regulatory compliance have different requirements. RI helps in meeting all these diverse needs.

So, what then constitutes the requirements for an ideal RI approach? An ideal 3600 RI support must encompass and support regulatory functions of Global Regulatory Affairs, Quality Assurance, CMC, Submissions, Labeling, Artwork and Packaging, Pharmacovigilance, Supply Chain, Technology and IT, Regulatory Policy, and Marketing.

From a bird’s eye view, the RI process seems effortless – gathering data, analysing information, and creating a regulatory strategy. RI is the key to unlock superior regulatory submission strategies and new market decisions. However, each step in this process includes a multitude of steps and brings with it its own set of challenges.

A comprehensive approach to RI

A wholesome approach for RI includes:

• Primary research that covers data sources across country updates, regulatory updates, congress coverage, trade associations coverage, authority and ministry coverage, key opinion leaders, and key influencers.
• Secondary research that encompasses data about country/product regulatory landscape, ongoing literature review, regulatory updates, clinical intelligence, HA updates, news and research, regulatory precedent of the policy, impact on the policy, lead countries and follow up countries.
• A technology solution that is a web-based, metadata-driven RI platform, real-time tracking and update, multiple information sources, actionable, auditable, collaborative social, and compare documents, regulations, and requirements globally.
• GRX Framework – IMPACT integrated with other technologies, in-house integration with DMS, PLM, submissions and other software, reusable content.
• Real-time distribution and action, real-time impact assessment of regulations and changes assign activities across departments for timely action
• Reporting and audit – Country/product specific comprehensive analysis, Newsletters and periodic reports, real-time news updates, on-demand reports, audit actions for compliance with changing regulations.

Another key aspect of regulatory compliance for organisations is being synchronous with regulatory policy and unmasking the gaps between regulatory policy and RI. Paving the way for the synchronous functioning of an organisation demands relentless efforts and support – both technological and functional.

As shown in Figure 1, every organisation should create an internal regulatory policy to comply with the HA policies and laws. Organisational policies need to govern internal procedures and processes. The RI data form the input for refining and enhancing existing policies.

Value proposition of RI

RI can be gathered, assessed, and used across various stages of the product life cycle. Its value proposition is immense in understanding the current trends and taking necessary actions for addressing both; functional and business needs of an organisation. As described in Table 2 and Figure 2, the value proposition of RI is multi-faceted and is significant throughout the product life cycle.

Regulatory strategy

A regulatory strategy is an authorised approach that coordinates with regulatory affairs to launch an overhauled pharma product/ device into a market, backed with a brilliant marketing plan. A regulatory strategy defines the plan for developing a product with the goal of obtaining regulatory approvals without any hassles in the desired markets. It also includes a plan for life cycle management/maintenance.

The regulatory strategy process aims at offering a comprehensive elucidation of the project, apart from distinguishing the relevant regulatory elements that need to be addressed to promote the product.

A global regulatory strategy program must fulfil the following criteria:

• Fundamental target product profile – The marked analytical implications alongwith predictable labelling petitions of the product should be configurated with the fundamental target product profile
• Changing regulatory environment – The program shall determine the continuously evolving regulatory environment that further involves the pursuit of a revived legislation and standards for requirements
• Facilitate new development tools – The program should leverage newly acknowledged development tools that save time and expense. Those tools should also ardently enhance compliance of foreign data to access global markets
• Predictable future approval requisites – The program shall determine predictable future approval requisites aligning with present approval prototypes and progressing clinical programs. The requisites may include comparisons, deadlines, statistical paradigms etc.
• Proactively recognise challenges – The program should ardently recognise challenges that are responsible for delaying analytical development. It should also explain the creative approaches initiated to circumvent these challenges.
• Distinguish key opportunities – The program should be able to distinguish key opportunities to engage global Regulatory authorities to assist these discussions.
• Eliminate developmental risk –The program should be able to eliminate the developmental risk if any, whilst boosting the potential for commercial success.

Multi-level approach for a product and country-specific regulatory strategy

In parallel to having a global regulatory strategy, it is equally important to have a country-specific regulatory strategy as companies tend to simultaneously start the registration process in multiple desired markets; particularly in emerging markets, to expedite the overall registration process and reduce their time to market. As shown in Figure 3, there are multiple levels in devising an effective regulatory strategy. A country-specific regulatory strategy is the most advanced level of RI and it must be specific to a particular product and company.

The key outcomes of RI and regulatory strategy:

• Timely and consistent submissions across global markets
• Effective approval process
• Uniform versions of documents
• Better planning for turnaround time and quality metrics
• Compliance
• Market-specific process adherence
• Harmonised documentation and quality standards across markets
• Policy and strategy
• Proactive product/market strategy
• Policy adaptation and internal/external influence
• Supporting business as usual
• Support day-to-day intelligence needs for micro and macro decisions
• Real-time knowledge support
• Accelerated training
• Impact on patient safety and brand image
• Consistency across markets impacting brand image
• Accelerated response to changes in regulations
• New regulatory opportunities and portfolio maximization
• Market-specific process adherence
• Harmonised documentation and quality standards across markets
• Centralised intelligence delivery platform
• Global submissions, dossier preparation, CMC management, artwork and label management
• Global intelligence-driven approach
• Compliance monitoring and business risk management
• Productivity, efficiency, and cost
• Informed decisions
• Improved compliance
• Intelligence-driven approach
• Internal links

To conclude, the right approach to RI will benefit in faster time to market, lesser cost for development, greater market potential, higher success rate, proactive regulatory decisions, global implementation, and improved operational excellence. What is your approach towards RI? Define it carefully and in a compliant manner. Stay informed. Stay compliant.

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Reverse brain drain is when people move in reverse, from a more developed country to a lesser developed country but one that is developing rapidly. These migrants may have accumulated savings and developed skills overseas that can be used in their home country.

India today has one of the world’s largest and most successful diasporas, with millions of expatriate Indians and people of Indian origin living across a wide range of countries, seeking more economic opportunity and material comforts. Over the last two decades, the next generation of people of Indian-origin have come to represent a highly skilled (doctors, scientists, engineers, professionals, and entrepreneurs) group of locals in every country they live in. According to the Ministry of External Affairs, over 13.6 million Indian nationals were living abroad as of February 2020.

The Indian leadership talent is fairly distributed across the globe. Below are few of the hotspots for NRI (non-resident Indians) senior executives across the globe. In addition to traditional hotspots like the US and UK, new hubs are developing in Southeast Asia, China, and the Middle East.

Reasons for reverse brain drain in India

However, throughout 2020, returnees have been hitting the reverse gear, due to growing opportunities in India, and more recently, the impact of the pandemic.

• India, a magnet for global healthcare investment, innovation and growth: Over the last few years, India’s healthcare and life sciences sector has been rapidly developing with increasing investments and a competitive edge in vaccines, generics among others. People have realised that India has more opportunities for professional development, wealth prospects and increasing quality to life. For instance, global in-house centres (GICs) are in many ways the future of global business. Their evolution over the past two decades shows that multinational companies (MNCs) have come to rely heavily on GICs, particularly in India, and not just for outsourced business functions with an eye on cost savings. Several enterprises have built global competencies and roles based in India and moved up the value chain to set up global centres of excellence in India.
• Turn entrepreneur: There is a lot of potential demand in India as it is a developing country where needs must be met. The population is huge and diverse, so there is a potential of high customer base. Private equity and venture capital have played the role of a lucrative springboard in providing growth capital for Indian businesses. In just the last few years, these two alternative investment channels have moved from a $10 billion opportunity to almost $50 billion in 2019. In fact, according to industry experts, PE/VC investments accounted for a remarkable two per cent increase in Indian GDP and a bigger boost to the overall economy
• Returning to run family-owned businesses: With second and third-generation entrepreneurs returning to run family businesses, companies are profiting from the experience they gained from working and studying abroad.
• Social and economic issues: Many countries are facing economic problems such as lack of job opportunities and increasing income inequality, immigration issues which are resulting in closing doors for Indian nationals. Indians with US degrees look at opportunities back home as America tightens immigration rules. The H1-B Visas are numerically limited with nearly 85,000 migrants each year in the US, out of which Indians get a significant H1-B visa approval. With Joe Biden being President-elect, it’s still unlikely to get easier.
• Other reasons include social and cultural life, living closer to parents, giving back to their motherland and retirement. People living away from their home countries feel somewhat ‘stuck in limbo, neither here nor there’. This feeling is quite understandable, given that for many, life in the host country is perceived as ‘temporary’. But, as time passes ‘home’ in the native country becomes more distant. The main concern is that while being temporarily abroad, the lives of one’s peers, relatives and friends back home move on too: families get established, careers progress and house mortgages get paid. And, though equipped with new skills, experiences and prospects, now of repatriation the recent traveller finds him/herself in a situation where a job needs to be found, new accommodation arranged, and social ties renewed.
• The COVID-19 pandemic impact: The pandemic has disrupted the lives of overseas Indians massively; there are increasing painful stories of the salaried class – layoffs across sectors, salary cuts and delayed increments have led to senior leaders thinking of coming back to India. It’s important to note that returning NRIs are those who stayed away from India for 8-20 years and are keen on working in India after they return. The retiring NRIs who lived abroad for over 20 years are typically settled with family. Hence, they are not very keen on returning.

Pros and cons of returnee talent (leadership level)

What does this mean for healthcare and life sciences companies?

India’s healthcare and life sciences sector has not managed to capitalise well on this unique and capable asset by actively attracting its human capital staying overseas. It is of utmost importance to understand their motivation and opportunities. Also, aligning their compensation expectations and tax composition, expected benefits and consideration for a smooth transition as they return to India are critical to address.

Largely, the returnee Indian workforce wants to move back to India’s metros due to better connectivity and quality of life, education opportunities for children among others. The home state is not seen as an important criterion in deciding the move back to India indicating flexibility and high mobility.

Roles and opportunities that would fit and attract returnee Indians

Most senior leaders prefer to work for an MNC or a large Indian organisation with global vision as they would wish to leverage their global exposure and contribute to the company’s growth in India. Some of the roles where these talents add value and fit well are

• Business functions and P&L leadership roles
• Consultancy and advisory
• Investment professionals or investor
• Social impact sector
• Functional leaders with emerging market remit
• Product Innovation
• Global manufacturing

The right talent is difficult to find and move. Companies will need to move beyond their traditional recruiting methods and networks to reach these candidates. A partnership with a global well-networked search firm with access to such talents would help organisations to persuade such talent.

The post Reverse brain drain: Accelerated by COVID-19 appeared first on Express Pharma.

As the world adjusts to the post-COVID-19 reality, it is time to reflect and reset. It cannot be ‘business as usual’ in the struggle to survive. The pandemic of COVID-19 has made everyone aware of the importance of masks and physical distancing. Yet the other silent ‘killer’ pandemic of antimicrobial resistance (AMR) that undermines health, including efforts to address COVID-19 is still unacknowledged.

AMR is the resistance of a microorganism (bacteria, parasites, viruses, or fungi) to an antimicrobial drug that was originally effective for the treatment of infections. When bacteria change in response to the use of antibiotics, they give rise to antibiotic resistance. AMR is one of the top ten global health threats which grows to undermine food security as well as sustainable development today. By 2050, it is projected to cause an estimated 10 million deaths per year and a loss of $100 trillion to the global economy.

Drivers of AMR include the irresponsible and indiscriminate use of antibiotics as ‘short cuts’ in human and veterinary sector in place of sustained improvements in infection prevention and control.

Unsurprisingly, in the interconnected ecosystem that we live in, AMR has other significant ways to spread. Effluents from animal farms, hospitals, homes and pharma plants are concentrates of antibiotics and resistant bacteria that contaminate the environment. A comprehensive ‘One Health’ approach that addresses these drivers in human, veterinary and especially the environment sector is needed to address AMR. The 2017 UN Environment Program Report categorically stated that the environment is the key to antibiotic resistance. Bacteria in soil, rivers and seawater can easily develop resistance by contact with resistance bacteria, antibiotics and disinfectants released by human activity.

India has one of the highest antibiotic resistance rates among bacteria that commonly cause infections in the community and healthcare facilities. In 2017, it announced the National Action Plan on AMR (NAP-AMR), based on the ‘One Health’ approach. It is historic as it declares the intention to ‘Strengthen India’s leadership on AMR’ as a key strategic objective besides ensuring surveillance of antimicrobial resistance – in human, animal and environment sectors (Strategic objective two).

As India rolls ahead with the much-needed ‘Atmanirbhar Bharat’ programme in pharma, it is the right time to lay the foundation for sustainable antibiotic production. The Indian pharma industry is the third-largest in the world by volume and 11th by value. With 3000 pharma companies and 10,500 pharma plants in the country, it produces 20 per cent of the world’s generic medicines and 60 per cent of the world’s vaccines. During the manufacturing process, there is a chance for residual material and active pharma ingredients to percolate into effluent water, which is then discharged into the surrounding environment. Scientific studies now delineate the important role of the environment, and more importantly, pharma effluents as an ecological driver in the emergence and spread of AMR. This can be easily addressed at the source.

The CDDEP report on Antimicrobial resistance in India (2017) listed 40 antibiotic API manufacturers and 250 antibiotic formulation companies manufacturing one or more antibiotics for human use. For AMR, the environmental contamination from the pharma plant effluents in these ‘hot-spots’ could be worrisome.

As part of the NAP-AMR implementation, India rolled ahead with the plan to develop standards for antibiotic residues in industrial effluents, particularly for those from pharma industries. It displayed its leadership in addressing AMR when in January 2020, the Ministry of Environment Forest and Climate Change (MoEFCC) released the draft standards for antibiotic residue in industrial effluent. The draft (Environment (Protection) Amendment Rules, 2019) provides stringent limits for 121 antibiotics and is also applicable to treated effluents from common effluent treatment plants (CETP) with membership of bulk drug and formulation units.

Since India (with China) manufactures almost 90 per cent of world’s active pharma ingredients (APIs) including antibiotics, the ‘Pharmacy of the World’ needs to address this issue for its own citizens. India’s leadership is being well acknowledged globally but these draft guidelines need to now be made mandatory. Additionally, the industry needs to put in place environment risk management (ERM) strategies in pharma plants. Efficient monitoring of these standards by regulators and adherence to the ERM strategies by the industry can be done meaningfully through public-private partnerships.

Interventions to address AMR from pharma effluents need leadership from both, the environment regulatory authorities and the pharma industry. The dynamic pharma industry and supportive regulatory system in India can establish key public-private partnerships that are needed to take concerted coordinated actions to tackle AMR in India. After all, we need to be united to save antibiotics!

The post Effective effluent management: Key to tackle AMR appeared first on Express Pharma.