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.

Counterfeit pharma jeopardise patient safety, infringe on intellectual property rights, and undermine the credibility of the pharma industry. Current methods of combating counterfeits are often time-consuming, expensive, and prone to human error.

The recent government announcement that 300 samples would have QR codes has some restrictions. QR codes can be rendered inoperable by scratching them off using a sharp object or marker. It is useless if the QR codes are broken. What use does the label serve, and who is responsible for making sure the QR code is still working when it changes commercial hands? What assurance is there that counterfeiters who can easily mimic a brand’s packaging, name, and logo won’t also be able to mimic its QR codes?

A more efficient and accurate solution is required to identify counterfeit drugs and protect public health.

Combining generative AI and image recognition is probably the answer. With the use of Google Lens and Generative Artificial Intelligence (AI) technology, a complex system for assessing photo metadata (Photo Meta Data) on pharma packaging and verifying the authenticity in real time.

I’d want to make a recommendation for pharma companies, government officials, and customers to combine the strength of AI with picture recognition to create a foolproof way to restrict the risks connected with counterfeit drugs.

*In 2018, Google Images introduced some new features to its image search results. Next to a selected photo, the creator of the image, the credit line, and a copyright notice are immediately displayed. This works by reading the corresponding IPTC photo metadata fields embedded in the image file. On August 31, 2020, this feature was enhanced to also display a licensable badge above an image and a link to the licensing information.

System requirements

a. Generative AI: Implement advanced Generative AI algorithms that analyse visual patterns, text, and packaging features to identify discrepancies between genuine and counterfeit pharma packs.

b. Google lens: Utilise the powerful visual recognition capabilities of Google Lens to capture and interpret codes on the packaging swiftly.

c. Cloud-based database: Establish a cloud-based database containing comprehensive information about authorised pharma products, including packaging details, manufacturing locations, and authorised distributors.

d. Machine learning: Train the system using machine learning techniques to improve accuracy and adaptability over time.

System workflow

1. Generative AI will be used to create unique invisible image tags for each product (like UID). This can be done by training the AI on a dataset of existing batch numbers, allowing it to generate new, unique invisible image tags on brand logo / brand name that cannot be replicated by counterfeiters

2. These unique image tags will then be printed on the packaging of each pharma product during the manufacturing process. (Covertly on Brand Logo and Brand Name)

3. Google Lens will be used by consumers to scan these image tags. Upon scanning, Google Lens will verify the code against a database of legitimate codes (image tags). If the code matches one in the database, the product is confirmed as authentic. If not, the product is flagged as potentially counterfeit.

4. In addition, the system can provide detailed product information, such as manufacturing date, batch number, expiry date, etc., to further assure the consumer of the product’s authenticity.

Key features and benefits

a. Real-time authentication: The system provides instant verification of pharma packs by scanning image tags using Google Lens and analysing visual patterns with Generative AI. This ensures rapid and accurate identification of counterfeit products.

b. User-friendly interface: Develop a user-friendly mobile application or web portal that allows consumers, healthcare professionals, and regulatory authorities to access the system easily and perform authentication checks.

c. Comprehensive database: Maintain a cloud-based database containing detailed information about authorised pharma products, enabling prompt comparison and verification during scanning.

d. Enhanced traceability: Enable pharma companies to track their products throughout the supply chain, reducing the risk of counterfeit products entering the market and facilitating targeted recalls if necessary.

e. Regulatory compliance: Support regulatory authorities in enforcing pharma regulations and combating counterfeit drugs by providing them with a reliable tool for inspections and investigations.

f. Consumer empowerment: Empower consumers to verify the authenticity of pharma products before purchasing, thereby increasing trust in the market and reducing the potential harm caused by counterfeit drugs.

Counterfeit pharma products are a growing global concern. By offering a scalable and reliable solution, our business aims to address the needs of pharma manufacturers, regulators, healthcare professionals, and consumers worldwide. The market potential is substantial, with potential revenue streams including licensing the technology to pharma companies, charging fees for database access, and offering premium services for enhanced features.

By harnessing the power of Generative AI with Google Lens for scanning image tags on pharma packs, proposed solution provides an efficient, accurate, and scalable approach to combating counterfeit pharma products. With enhanced authentication capabilities, regulatory compliance support, and empowered consumers, the solution aims to make a significant impact on public health and safety while fostering trust in the pharma industry.

The post Generative AI with Google Lens to detect counterfeits in pharma 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.

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Small and Medium Enterprises (SMEs) form the backbone of India’s economy, contributing significantly to employment generation and economic growth. However, one of the major challenges faced by MSMEs in India is delayed payments. This issue has far-reaching consequences, affecting the financial stability and sustainability of these businesses.

Reasons for delayed payments to pharma MSMEs

Inefficient cash flow management by large companies, including delayed receivables processing and elongated payment cycles, can directly impact SMEs by delaying their much-needed payments. Pharma MSMEs usually operate in a weaker bargaining position compared to larger companies. This power imbalance can be exploited by buyers, who may delay payments without facing significant repercussions. Pharma MSMEs may lack negotiating power or alternatives to deal with late payments effectively.

Many buyers, both private and public entities, are pulled into following delayed payment practices due to administrative inefficiencies, bureaucracy, continued thrust to better margins or a lack of awareness regarding the impact of delayed payments on pharma MSMEs.

Challenges faced by pharma MSMEs due to delayed payments

Delayed payments pose severe challenges for pharma MSMEs. It disrupts the cash flow of SMEs, making it challenging for them to meet operational expenses, pay employees, and invest in growth initiatives. This financial strain can even push some pharma MSMEs to the brink of closure. To bridge the gap caused by delayed payments, pharma MSMEs may resort to relying on expensive alternative financing options. This leads to increased interest costs and debt burdens, further impacting their financial health negatively.

Limited working capital due to delayed payments also restricts the ability of the industry to expand their operations, invest in new technology, or explore new markets. This hampers their growth potential and stifles job creation.

Further, delayed payments put SMEs at a disadvantage compared to large size counterparts, inhibiting their ability to compete effectively in the market.

Addressing the issue

Addressing the issue of delayed payments to pharma micro, small, and medium enterprises (MSMEs) requires a multi-faceted approach involving various stakeholders.

Government interventions are essential in driving change. Strict enforcement of existing regulations, such as the Micro, Small, and Medium Enterprises Development (MSMED) Act, 2006, is necessary to ensure timely payments to MSMEs. Penalties for non-compliance should be imposed to deter delayed payment practices.

The Union Budget 2023 introduced a modification to Section 43B of the Income Tax Act, aiming to allow buyers to claim income tax deductions solely for payments made to MSME suppliers. In essence, business entities cannot consider the expense eligible for deduction until the actual payment is made to the MSME seller. This proposal seeks to address the persistent issue of delayed payments faced by pharma MSMEs and offer them the necessary liquidity support they require.

Encouraging the adoption of digital payment systems and e-invoicing can streamline payment processes and reduce paperwork. Further, standardising payment terms and practices across industries ensures clarity and consistency, facilitating smoother transactions and timely payments.

Addressing the issue

Collaboration is key to addressing delayed payments. Pharma MSMEs should be encouraged to join industry associations, enabling collective bargaining power and a united voice to negotiate better payment terms with buyers.

Efficient dispute resolution mechanisms are necessary to resolve payment disputes promptly. Establishing dedicated arbitration centers or online platforms can offer accessible and cost-effective means for pharma MSMEs to seek a resolution and recover their dues.

Promoting awareness and accountability is also vital in changing mindsets and practices. Awareness campaigns should educate both buyers and MSMEs about the detrimental effects of delayed payments. Emphasising legal obligations and penalties associated with late payments raises accountability and encourages compliance. Creating reporting mechanisms or platforms where MSMEs can anonymously report instances of delayed payments can help identify repeat offenders and foster transparency.

To boost timely liquidity in the hands of pharma MSMEs, the financing of business transactions at Trade Receivables e-discounting system (TReDS) platforms should be incentivised by the government. Such incentives should be provided to all the stakeholders involved in TReDS financing transactions i.e MSME supplier, buyer – private as well as public and banks/financial institutions.

By implementing these strategies, a more supportive environment can be created for MSMEs and it can help to address the issue of delayed payments to pharma MSMEs in India.

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Nobody is likely to have a difference of opinion that the medical system and the processes have evolved as a result of knowledge, necessity and the prevailing medicines and antidotes available in different regions. This is true for the whole world whether it is America, Japan, China, Europe, India, the Amazon or wilds of Africa. The diseases and abnormalities with the human body (animals as well) are not new.

The chemical drugs, if we consider natural salts, acids and alkalis, are not too old either. Their utility and justification to be used took a long time. The pharmacopoeias across the world, be it from the US or Britain and even India are hardly 200 years old (first USP was published in 1820) and Indian Pharmacopeia in 1955. Most of the monographs were about tinctures, aromatic waters, extracts, syrups derived from natural products and few chemical salts and drugs chemically identified and synthesised. Same stands true for others’ compendium as well.

Aspirin, the most notable chemically modified drug, came into being in 1897 and the penicillin was also a chance event in Alexander Fleming’s lab in 1928. Its commercial success was achieved by collaborative efforts of the US and the Great Britain in 1943. This product was also not chemically synthesised, rather it was manufactured at a mass level by fermentation. The most sought after analgesic, morphine comes from opium or the poppy plant.

My point is why there is a clash and antagonism in recent times. In India, the drug industry flourished from drug substances and drug products of vegetable/herbal origin and one can see the billion-dollars companies growing phenomenally with such products. The scientific and clinical evaluation must not be side-lined or ignored. Chemical-based drugs can also be equally dangerous and therefore they are declared safe only after decades of evaluation, no chemical substance is declared a drug overnight.

My apprehension is: Why are we not able to bridge the gaps and claims from different systems of medical practices and assure people to use current practices of medicines with confidence as well as best and prompt results.

Our people are never affected by the hospital charges or doctors’ fees but they experience a volcanic impact by the fuel prices and drug prices. This is an unending discussion and the problem is further fuelled by generic and branded generics propaganda. Public advertisements for discounts on drug prices ranging from 20 to 90 per cent instil more and more suspicion in the minds of people about profiteering and its magnitude by the drugs manufacturers. I don’t know who to thank for free medical education to all (literate and illiterate with live examples like a street juggler) and treatment for the most dreadful diseases and their prevention, that’s being imparted every morning on national TV. The government must reconsider their plans, expenditures and investment policy for national health in view of brutal condemnation (sponsored and endorsed) of the modern-day medical practices, practitioners, profession, medicines and research. There is greater emphasis to revive the traditional medicine system with scientific rationale and clinical evidence.

To bring down the cost of treatment, we are all out to fight for the allopathic drug prices, I think it may be possible, otherwise how the 10 to 90 per cent discount is offered. Do we ever consider to put a limit on the professional fees and charges by attending doctors and hospitals? It will be desirable to have a look at the prices and the cost of the drugs in the Ayurvedic category too, most of the drugs are taken in multiple units every day for months together.

The purpose of this article is not to compare or show superiority of one over the other. It is meant to educate ourselves and collaborate for the welfare and good health of mankind. Utilise the resources and facilities for the maximum benefit and develop a sense of responsibility and accountability. Let science prevail, irrespective of the medical system practised. Stop condemning the modern medical practices instead develop confidence of the patients in the treatment and medicines.

Over and above, leave the profession of healthcare to professionals and let politics and governments talk about infrastructure, budgets and social welfare. Stop irrational advertising (including OTC drugs that leads to abuse, overdosing, habituation and loss of efficacy). If the professionals are not awakened then they are going to lose their integrity and relevance.

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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.

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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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Chushul Suri, Founder and CEO, Medbikri highlights that the use of advanced digital technologies has improved inventory management in pharmacies by making it more secure and cost-effective

Pharmacies have always been an integral part of the Indian healthcare system. It is the link between a doctor’s prescription and patients acquiring the medicines to recover from their illnesses. Over the years, the world of healthcare has evolved rapidly, and digital technology has played a crucial role in transforming the industry, including the way pharmacists operate. From automated inventory management to teleconsultation, digital technology is helping Indian pharmacists provide better patient care, reduce costs and streamline their operations. The value of India’s retail pharmaceutical market is estimated to touch $59 billion by the fiscal year 2023, which presents a promising opportunity for retail pharmacies to bolster and strengthen their operations.

Here are some of the ways in which technology is changing the face of pharmacy in India and benefitting the pharmacists, patients and the healthcare system as a whole-

Improved inventory management

The use of advanced digital technologies has improved inventory management in pharmacies by making it more secure and cost-effective. Digital technology solutions, such as pharmacy inventory management systems, have turned out to be game changers. These systems have helped pharmacists efficiently manage their operations, enabling them to generate more revenue. Features such as updating store inventory details by uploading purchase bills significantly reduce the time in data entry, allowing pharmacists to focus on more complex work. Cloud technologies have made inventory management systems scalable, with features that allow pharmacies to prevent wastages or stockouts. Inadequate management of medicine can result in shrinkage or loss, which can have serious consequences. However, a management system can help ensure the security and availability of all medicine stocks, resulting in cost savings. Other related technologies such as scanning barcode labels on packages have also facilitated electronic purchasing and procurement on a larger scale.

Increasing efficiency through billing software

Medical billing software helps streamline the sales process by automating tasks such as generating electronic bills in just seconds. Pharmacies can easily send digital bills to customers via WhatsApp or SMS, rendering the process less cumbersome and resulting in increased footfall due to the ease of experience. Relying on digital instead of paper bills also ensures that pharmacists save time, costs, bring more value to the patients and remain sustainable at the same time. Certain online pharmacy billing software also maintains a database of medicines and health products, making it possible to track the stock of drugs and other health-related items that require replenishment. Additionally, such software also provide insights into customer preferences, including the best-selling products and the ones that are less popular.

With the help of digital tools, pharmacies are also alerted when patient prescriptions are expiring and require refills, helping businesses ensure a steady stream of revenue and engage with customers in a better manner and gain their trust. Pharmacists can improve customer service by sending reminders or notifications to chronic patients when their prescriptions are running low, enabling them to always have their refills on time.

To further grow their businesses, pharmacists can also use online pharmacy software to analyse market trends and customer behaviour, enabling them to develop effective marketing and outreach strategies, sell additional products and increase sales.

Telepharmacy

Digital technology has facilitated telepharmacy services, enabling patients to connect with qualified pharmacists remotely. This allows for remote drug selection counselling, prescription checks and dispensation of medicines. This is particularly useful for patients with long-term illnesses in rural areas or in emergency cases where there may be a shortage of healthcare professionals and onsite pharmacy services. Telepharmacy eliminates travelling costs for patients and reduces the burden on the healthcare system. Digitisation is also helping many pharmacies transform into e-clinics, improving the pharmacy’s bottom line and helping them retain customers. With nearly 100 crore Indians residing in smaller cities that often experience a shortage of doctors, local pharmacies can bridge the treatment gap by providing online doctor consultations and prompt medicine deliveries.

Digital technology has greatly impacted the way Indian pharmacists operate and has led to improvements in inventory management, sales processes, and customer service along with streamlining of operations and reduction in costs. By leveraging these technologies, pharmacists can focus on providing better patient care and engagement, resulting in increased trust and loyalty from customers. As the healthcare industry continues to evolve, the integration of digital technology will undoubtedly play a significant role in shaping the future of pharmacy in India.

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Rajnish Gupta, VP & Head, India and Sub-Continent business, Zebra Technologies APAC emphasises that organisations can offer a convenient and more personalised experience to their customers to build trust. Industry research has shown that companies focused on the human experience are more likely to outperform their peers in revenue growth

Online pharmacies or “E-pharmacies” have been on the rise in India as consumers realise the ease of receiving medications in the comfort of their homes. In the last couple of years, the Indian government has classified E-pharmacies as an essential service and promoted them on the Aarogya Setu App, after realizing the effects of the pandemic. PM Bhartiya Janaushadhi Pariyojana, Digital India, Ayushman Bharat, Startup India and National Digital Health Mission (NDHM) are some of the initiatives undertaken by the government to boost the online pharmacy sector. As the healthcare sector is redefining its approach to focus on patient comfort, a critical factor to drive patient loyalty is to maintain transparency and agility in the supply chain.

High expectations, low tolerances

Eighty-five percent of patients say pharmacies need to monitor the quality and integrity of medications they dispense, with over half holding pharmacies responsible for ensuring medications are kept safe and uncompromised within pharma supply chains. Pharmacies must show patients that they prioritise patient health and safety if they want them to choose their pharmacies.

Pharmacies must also do everything in their power to keep shelves consistently stocked. If customers are unable to get their medications at one pharmacy or in a single visit, they may be more inclined to go to a competitor down the street or even a mail-order pharmacy in the near- and long-term. Likewise, if they feel they are overpaying at a pharmacy, they will probably shop around unless there are other reasons to stay loyal, such as a strong relationship with the pharmacy staff, convenience, or consistent medication availability.

How technology can help build trust and loyalty

It is not easy keeping medication costs down while preserving profit margins in today’s market. However, there are ways to help lower overheads and give pharmacies more flexibility in medication pricing models. There are also ways to show patients that pharmacies can be trusted to put patient needs ahead of business needs. There are many ways in which technology can help build patient trust and loyalty in the long term.

One such method is moving beyond the barcode. Handheld and fixed radio frequency identification (RFID) readers can capture data from thousands of RFID-tagged pharmaceutical items each second, enabling staff to keep better tabs on what is in stock, what needs replenishment, and what is approaching expiration. RFID can also help with medication authenticity on inbound inventory.

We can use practices such as showing the patients that shipped medications have not been compromised. Adding visual temperature indicators that are simple for patients to read and understand is one way to build trust in the quality and safety of shipped medications. Patients will not likely call about a suspected temperature excursion – and request a costly replacement – when they can clearly see that their medications did not get too hot or cold during transit.

Organisations can offer a convenient and more personalised experience to their customers to build trust. Industry research has shown that companies focused on the human experience are more likely to outperform their peers in revenue growth. This includes putting systems in place that help pharmacy staff get to know and treat patients and make it easy for patients to access pharmacists in the first place, especially in case of a mail-order pharmacy that does not have the luxury of building relationships via face-to-face interactions.

If the pharmacy has a long queue, consider setting up self-service kiosk stations or mobile applications that enable patients to submit orders, consult with off-site pharmacists, or even look up medication information based on personal information retrieved from their electronic health records (EHR). With the right technology in place, it will become easier to provide patients access to well-informed experts who can deliver valuable information in a personalized way – that ultimately builds trust and loyalty.

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The vaccine efforts of the COVID-19 pandemic highlighted our knowledge about gaps in the immune system. Reductionist systems, such as genetically identical inbred mice, have long been the choice for immunology research, which focuses on studying the cells, tissues, and organs that make up the immune system. However, the spotlight has shifted to unravelling the complexities of the human immune system. This article outlines the challenges of conducting human immunology research in a developing country.

A different approach to study the human immune system

While model animals are valuable tools, it is apparent that they may not always accurately predict the behaviour of the human immune system. The TGN 1412 trial serves as a great example, where a drug deemed safe in animals resulted in life-threatening consequences when tested at a much lower dose in humans. Another reason to focus on human immunology is the heterogeneity in immune responses, which may not be accurately reflected in model organisms. Therefore, it is particularly valuable to characterise the baseline as well as the breadth of immune responses in India, which includes people from different ethnic groups, ages, dietary patterns, and socioeconomic backgrounds. Lastly, India faces a significant burden of tropical diseases, such as dengue, chikungunya, and malaria, and also faces a threat from emerging or rare infectious diseases. Thus, understanding the human immune system is crucial for improving disease management strategies and being prepared for future outbreaks.

Studying immune cells

The most accessible source of immune cells is blood, and a significant portion of human immunology research has been conducted using blood samples obtained from participants in regulated, ethically conducted studies with informed consent. Studying immune cells in the blood can provide insights into their behaviour and role in pathogen control. However, blood cells do not present the entire picture. Many immune cells in tissues may look and behave differently from cells in the blood, and some immune cells never enter the circulation and reside in tissues. Characterising immune cells in human tissues, such as lymph nodes obtained from surgical waste during living donor transplants or biopsies remaining after clinical use, has proven useful in addressing this gap. More recent studies have also utilised samples from recently deceased organ donors who consented to research. The advantage of using such samples over surgical explants or biopsies has been highlighted in the work by Dr Donna Farber’s group (PMID 28719147), which is not discussed in detail here.

Immunology studies in India: Steps we can take

Human immunology studies in India require several key components to support high quality research, including a regulatory framework, effective clinic-research lab partnerships, infrastructure, and funding. Recognising this, some upcoming research institutes in India have invested in these aspects to support scientists interested in human immunology.

A robust regulatory framework is necessary to address the ethical and biosafety considerations unique to human sample research. While regulatory bodies for this purpose already exist, it is essential to establish rigorous yet reasonable rules governing human subject research. High-quality training modules, contextualised for scenarios encountered in India and available in multiple languages, are crucial for training personnel at all levels to execute research with high standards. Institutional support, such as expert consultants, essential document templates, and protocols for regulatory submissions, is also vital. Finally, public engagement in research has to be sought through informal group sessions communicating the purpose of the human research in plain language.

Similarly, institutes that facilitate connections between local hospitals and research institutes play an essential role. India boasts a large community of qualified physicians and scientists, but fostering more synergistic associations between the two is necessary. This can be achieved through the creation of short-term paid positions for clinicians to train with research groups and for research groups to engage in medicine or public health-related community service. Although collaborations of this nature already exist, they tend to be concentrated in major cities. To enhance outbreak preparedness and gain valuable local information, it is important to extend these networks to smaller research institutes and hospitals in towns and rural areas.

The requirement for infrastructure encompasses not only specialised equipment but also the substructure necessary to support that equipment over an extended period. For example, frequent power outages can impact the lifespan of equipment, and backup power may not be sufficient to support power-consuming instruments. Purchasing energy-efficient equipment, rather than solely considering the lowest cost, could potentially reduce strain on power consumption.

Immunology research heavily relies on consumable reagents, such as fluorochrome-coupled monoclonal antibodies, MHC tetramers, and various types of tissue culture tubes and plates. Currently, these reagents are mostly imported through distributors, adding significantly to the cost of experiments (due to refrigerated shipping costs and import duties). Another hidden cost is the time taken for reagents to reach the lab, or in some cases, the reagents not clearing customs at all. To alleviate these challenges, local production of such reagents would reduce costs, shorten delivery times, and stretch research budgets further. However, one hurdle to local production is that reagents not involving innovation or point-of-care products are not considered market-worthy. Moreover, human immunology research in India is considered too small a market. To break this cycle of no supply no demand, increased funding for local production of research reagents by academic units (when intellectual property is not a concern) is necessary, not just for point-of-care devices or novel technologies.

Way forward

Human immunology research holds promising potential in India, but it requires a collective scientific will, collaborations and increased clinical and research partnerships to gain momentum. By fostering these partnerships, investing in infrastructure and regulatory frameworks, and supporting local production of research reagents, India can pave the way for significant advancements in understanding the human immune system. This knowledge will not only contribute to better disease management strategies but also ensure preparedness for future outbreaks, benefiting the health and well-being of the Indian population and beyond.

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