Even as the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, is held in abeyance till further notice, it has strengthened the call for quality medicines. Let us examine the possible impact on the pharma sector.

Speaking for most doctors, the Indian Medical Association (IMA) compared the National Medical Commission’s (NMC) push towards promotion of generics as “running trains without tracks’’, reasoning that not all generic medicines are of the same quality as their branded counterparts.

In contrast to the IMA’s stance, the Alliance of Doctors for Ethical Healthcare (ADEH) has put out a statement urging the NMC to reverse its decision to put the directive in abeyance. Their suggested solution: issue a “fresh, improved directive mandating doctors to write prescriptions in generic name only with the company name in the bracket if any RMP desires to”.

The ADEH statement points out that as generic names are used during the training of doctors in pharmacology and all clinical subjects, they should be allowed to continue to write prescriptions in generic names until the government can assure through concrete evidence that all medicines available in the market are of standard quality. In the absence of such reliable assurance, doctors have to rely on the company’s reputation, his/her individual experiences as well as of fellow doctors.

The ADEH statement also suggests that within five years, there should be a move towards a situation in which all medicines in India are of standard quality, whatever may be the manufacturing company. To monitor the progress towards this end, ADEH suggests that National Drug Surveys should be carried out based on representative samples of medicines in the retail market. Once this goal is achieved, all brand names should be gradually done away with.

They also urged the government to ban all irrational Fixed Dose Combinations (FDC) that constitute around 40 per cent of the retail market in India compared to seven per cent in World Health Organisation’s Essential Medicine List. Writing generics in prescriptions, the ADEH stated, becomes a huge challenge if irrational FDCs with multiple ingredients are to be prescribed using generic names.

What do these recommendations mean for the pharma sector in India? Spanning companies of all sizes, the sector is only as strong as its weakest link. Smaller pharma companies do not always have the finances to put quality systems in place, yet contribute to affordability and access. Should the government crack down hard on quality, most MSME pharma companies are likely to fold up. Not only will this be a loss of livelihoods, it might impact medicine prices.

A crackdown on quality seems inevitable. Even though GMP norms are officially in place, recent global criticism on pharma quality triggered by children’s deaths linked to cough syrups made in India, have shown that implementation is patchy to say the least. In early August, Union Health Minister Mansukh Mandaviya announced new timelines for adoption of GMP norms. Pharma companies with an annual turnover of over Rs 250 crore have within six months, those with a turnover of less than Rs 250 crore have six months more to adopt GMP norms, else may be penalised. Will the GMP laggards fall in line this time?

Also, pharma companies might need to lay off their armies of medical representatives (MRs) if doctors cannot prescribe brands. While some part of this salesforce might be needed to shift build rapport with the pharmacy-distributor side, it’s fair to say that the NMC regulations will change the rules of pharma marketing.

The NMC’s regulations prohibit doctors and their families from accepting gifts, fully-paid trips to medical conferences, etc. These restrictions are already part of the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) which are supposed to be followed by all pharma companies, as all major pharma associations have accepted this code. Inspite of periodic attempts to make it mandatory, the UCPMP has stayed voluntary.

Will NMC’s attempt to shift the onus on the receiver (rather than the giver) make a difference? There are already reports of doctor associations finding loopholes in the NMC’s regulations. For instance, in the case of medical conferences, the association is free to accept sponsorship from pharma companies but not individual doctors.

The NMC diktat has resurrected important debates on the loopholes in pharma manufacturing and marketing. It is high time these weak links are addressed and fixed once and for all.

The post NMC generics diktat strengthens call for pharma quality  appeared first on Express Pharma.

The centre-state power equation works well in theory, as a system of checks and balances. But practice has been anything but perfect

Of the 32 bills awaiting discussion during the ongoing 2023 Parliament Monsoon Session, the Drugs, Medical Devices and Cosmetics Bill, 2023 is one of 21 new draft legislations. Once passed, this will replace the Drugs and Cosmetics Act, 1940.

However, not everyone is on board with the proposed Bill. Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) says that although the draft of the Bill has not been shared with stakeholders yet, they expect that it will incorporate several thoughtful provisions from the Medical Devices Rules 2017.

He points out that the regulation of Medical Devices currently operates under The Medical Devices Rules (MDR) 2017, a well-considered framework that emerged through extensive consultations between CDSCO and various stakeholders. Choudary further adds, that they strongly recommend that the industry is consulted and given an opportunity to submit their recommendations before the Bill is finalised. His point is that advancing the inclusive approach that the government has adopted so far, would help it avoid blind spots and enable the supply of quality products to continue uninterrupted.

From the pharma sector, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA) reiterates that quality is fundamental, and this (the proposed Bill) will help to strengthen quality management systems in the country and take our industry to the next level.

Echoing these sentiments, Suresh Pattathil, President, OPPI comments, “…we find confidence in the thoughtful integration of provisions of the acclaimed New Drugs and Clinical Trials Rules, 2019 (NDCT), Medical Devices Rules 2017 (MDR) and the Cosmetics Rules, 2020. All these framed rules stand as a testament to the power of collaboration, arising from extensive consultations between CDSCO and diverse stakeholders. In nurturing this progressive legacy, the government’s inclusive approach fosters a horizon of transparency and foresight. By removing blind spots, we pave the way for an uninterrupted flow of quality products, enriching the lives of those we serve. Together, we aim to uphold the highest standards of safety, efficacy, and accessibility, empowering healthcare for all.

In contrast, sources from the pharma MSME segment allege that while the stated purpose is quality and to replace the archaic Drugs and Cosmetics Act 1940, the real purpose of the proposed Bill is to ‘strangulate 8000-10000 small units and facilitate Big Pharma’. They allege that the proposed Bill is an attempt to unconstitutionally divest state drug regulators of powers, and aver that such changes cannot be made as long as medicines are on the concurrent List.

If this sounds familiar, that’s because it is. MSME players in any sector are bound to play the underdog card. Secondly, the centre-state power equation works well in theory, as a system of checks and balances. But practice has been anything but perfect. As drugs/medicines are on the concurrent list of the Constitution, the centre legislates and states implement the regulated manufacture and sale of medicines.

Supporting their argument, pharma MSMEs experts single out the relevant sections in the new Bill like Section 41(5) of the proposed Bill which creates a Central Licensing Approving Authority, meaning that no unit can be licensed without its approval. Section 41 (6) of the proposed Bill empowers the Central Government to assume control of manufacture and sale of medicines by issuing a Notification. Similarly, Section 68(2) enables the Central Government to cancel any license.

They point out that this is the third attempt to centralise (pharma regulation), alluding to previous attempts in 2007 and 2013, which were stymied when the Parliament Standing Committees rejected the Bills. The 79th Report of the Standing Committee on Health and Family Welfare also reprimanded the Central Government for misleading the Parliament. Given past censure, these sources note that the new bill is not being sent to the Standing Committee this time.

It’s easy to understand why pharma MSMEs are on the backfoot. Starting with cases in Gambia, the past year has thrown up multiple instances of MSME pharma exporters cutting corners on GMP, resulting in tragic deaths due to medicines containing non-pharma grade solvents. State drug authorities gave these companies a clean chit, even though some were multiple offenders.

Conceding that these incidents could be the trigger for this latest attempt to centralise pharma regulatory powers, pharma MSMEs claim bad policies force them to cut corners. They argue that the Central Government should own up responsibility as ‘the manufacturer alone is not the culprit’.

Blaming policies like tax holidays to hill states, followed by increasing excise burden to 30 per cent by levy of MRP excise, pharma MSMEs say they had to cut corners on quality to survive, ‘resulting in Gambia and Uzbekistan.’

They also allege that no more than 10 per cent MSMEs can comply with the inspection format and more stringent GMP norms which came into effect post 2005.

Pointing out that while India currently is fortunate to have a grid of skilled workers and technology to qualify as the Pharmacy of the World, they warn that if pharma MSMEs are closed down, the capacity to produce affordable drugs will be lost forever. In addition, the country loses employment to crores who make and sell drugs as part of the pharma MSME sector.

Referring to multiple instances when FIRs have been registered against officials in CDSCO, sources in pharma MSMEs wonder how the proposed Bill seeks to make the same body and officials more powerful. Their contention is that while state inspectors are answerable to multiple tiers of state government which are accessible, CDSCO inspectors are not subject to such oversight, which raises their corruption levels.

Ironically, while India’s medicines watchdog the CDSCO is facing flak here, its US counterpart is in the same boat. A recent letter from the US House Energy and Commerce Committee to the FDA Commissioner, expressed concern regarding the effectiveness of the FDA’s foreign drug inspection programme, stating ‘we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.’

It is true that medical expenses push more Indian citizens below the poverty line each year, and pharma MSMEs create competition which keeps prices more affordable. However, maintaining quality standards is equally important.

While the blame game between centre and state regulators, as well as large and MSME pharma companies continues, let’s hope that legislators get a fair chance to debate the proposed bill and if not satisfied, ask for changes or defer it pending further discussion.

The post Proposed new drug law may still have flaws appeared first on Express Pharma.

The theme for the Indian Pharmaceutical Alliance’s flagship event, the Global Pharmaceutical Quality Summit, was Patient Centricity and the Future of Manufacturing and Quality. A pertinent choice, given the reverberations from children’s deaths across at least seven countries, which have been linked to Made-in-India cough syrups and other formulations. The comments of global regulators at the IPA Summit are additionally significant when viewed against this tragic backdrop.

Big India pharma finds itself on the back foot, thanks to such recurring incidences. Speaking during the inaugural session, Nilesh Gupta – Chair, Quality Forum, IPA and MD, Lupin asserted that “the priority is to deliver a quality product, consistently.” His comment that “capability building within the India pharma sector is key to play its role in the transformation of India into a developed nation” reflects the stark reality of the wide variation in quality standards of medicines within the country.

S Aparna, Secretary, Department of Pharmaceuticals, Government of India, in her keynote address during the inaugural session, referred to another widely accepted variation: India’s vast geography and federal structure translates into multiple levels of drug regulation, with varying degrees of capabilities, requiring continuous capacity building measures within the regulatory body itself.

But her hopes that the IPA Summit would motivate more MSMEs to seek the schemes launched by the government to help them upgrade their quality systems needs to be emphasised beyond IPA’s membership of the 20-odd big Indian pharma companies.

Fortunately, IPA Secretary General Sudarshan Jain revealed that IPA’s quality workshops have now been opened to non-member companies as well. That’s certainly a good move. The cases highlighted in Gambia and then across more countries, prove that medicine quality can no longer be treated as a competitive advantage, with best practices being marked ‘For Members-Only”.

The Secretary, DoP’s message was reiterated by Rubina Bose, Deputy Drugs Controller India, CDSCO during a panel discussion with representatives of three global regulators: Sarah McMullen, Country Director, India Office, Office of Global Operations, USFDA; James Pound, Deputy Director Standards and Compliance, MHRA and Thomas Hecker, Inspector, Certification of Substances Department, EDQM.

Despite the negative connotations of import alerts and post-inspection observations, the global regulators on the dais seemed to call for a more holistic view of inspections. For instance, McMullen said that the “US FDA does not expect perfection”, reasoning that while problems do occur, what counts is how companies handle these identified issues. This was echoed by the EDQM’s Decker who said it was more important to understand how a company responds to issues flagged during inspections.

When moderator Shirish Belapure, Senior Technical Advisor, IPA joked that pharma heads in India were cancelling vacation time, thanks to the multiple inspections being conducted at pharma plants, Decker wondered why that was so. His reasoning that once good (quality management) systems were in place, teams would manage inspections even in their seniors’ absence triggered a wave of uneasy chuckles from the audience. The reaction exposed a crucial fault line: just how much do written SOPs reflect actual practice?

Regulators are plugging loopholes and tightening laws to safeguard patients. For instance, the US FDA issued a guidance in May 2023, alerting pharma manufacturers, to the potential public health hazard of glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG).

It is well known that both contaminants enter the pharma supply chain, either due to negligence or willful mixing of pharma-grade glycerine with its industry-grade equivalent. Scant or faulty analytical methods do not catch the contamination. The contamination or mixing of both grades of solvents is most likely deliberate, as there is a vast price difference between the two grades. It is difficult to trace back such ‘contaminated’ solvents to rogue traders, as there are multiple selling points and smaller pharma companies do not document all such purchases.

Over the past few months, India’s drug regulator CDSCO has also upped its game. Reports suggest that 209 pharma manufacturing sites, known for previous GMP violations, have been jointly inspected by both central and state drug inspectors. 71 companies have been reportedly issued show-cause notices, and 18 companies have been asked to shut down.

In addition, in May, CDSCO mandated that all cough syrups due for exports would need to be checked at Central/ State Drug Testing Laboratories. This has however created a backlog of cough syrup samples at certain labs. On June 13, CDSCO announced that it would update the number of batches of cough syrups it receives at each of its labs so that companies send their samples to labs with fewer samples.

However, these steps do not seem to be enough. Putting a question mark on the test reports from government-controlled labs, Gambia’s Medicines Control Agency mandated that from July 1, all medicines exported from India to Gambia would first need to be tested at a designated private lab in Mumbai. The detailed pre-shipment document verification, physical inspection, quality control testing and issuance of Clean Report of Inspection and Analysis for pharma products now mandated by Gambia will probably delay exports and add to the costs. Will other countries follow suit and risk medicine shortages?

The IPA Summit ended with the Union Health Minister Dr Mansukh Mandaviya’s assertion that ‘the Government has a zero-tolerance policy against those who compromise with the quality of the medicines.” He also urged the industry to establish a self-regulatory body to maintain the quality of the pharma products. Is this an attempt to shift responsibility to pharma associations, even though this strategy has not worked as well as it could so far? Clearly, both the regulator and the regulated need to move faster to salvage lost reputation.

The post In search of consistent quality appeared first on Express Pharma.

A recent report that Spain may invest in India’s bulk drug parks is good news for both countries. The 12th Session of India-Spain Joint Commission for Economic Cooperation (JCEC) held on April 13 in New Delhi saw both governments agree to strengthen their collaboration in several key sectors, including pharma.

The two countries are natural allies in the pharma segment, as they seek to diversify their supply chains for APIs and bulk drugs. As Spain gets set to assume Spanish Presidency of the EU, from July to December 2023, one hopes that both governments can negotiate and finalise the terms of the collaboration, as bulk drug parks are critical to India’s hopes of retaining its reputation as the pharmacy of the world.

There is no doubt that retaining the pharmacy of the world title will only become tougher, as many countries hustle for the same claim to fame.

For instance, even as pharma companies continue the long-term process of reducing dependence on outside sources for key input materials, revenues from the US generics market remain subdued. This has forced Indian pharma companies to hedge their bets and focus on RoW markets. Luckily, the India domestic market has some sweet spots. A review of analyst reports on the Q4FY23 and FY23 results show some interesting trends.

For instance, an ICICI Securities report predicts that while there may be some near-term green shoots in the US generics market, the macro outlook remains the same. Not surprisingly, the report predicts that pharma companies with specialised R&D skillsets will likely be able to tide over the transformation better.

Giving some relief, India branded formulations segments seem better placed, with growth predicted to pick up from Q2FY24. The ICICI Securities report points out how strong brand recall, an asset-light business model and low R&D investments ensure best-in-class EBITDA margins. Companies operating in India are therefore well positioned to benefit by virtue of their lean balance sheet with steady cash flow.

Cutting down on R&D investments is not an ideal strategy for the long term, but it’s understandable that faced with tough choices, pharma companies are doing their best to balance short-term liquidity with long-term R&D investments.

The good news is that while the profitability of the India business was temporarily disrupted due to mandated price cuts on NLEM products and raw material inflation, from April 2023, pharma companies may start taking ~12 per cent price hike on products under price control and up to 10 per cent on the rest, thereby improving their margins. Better diagnosis and access to quality healthcare services are likely to boost volumes in India in the near term. The ICICI Securities report expects an 11 per cent CAGR over FY23E-FY25E in India formulations.

A second report from CRISIL Ratings offers more perspectives. Predicting some growth in the US generics market, Anuj Sethi, Senior Director, CRISIL Ratings reasons that increased inspections by USFDA after the pandemic and higher withdrawals of abbreviated new drug applications (ANDAs) due to intense competition are leading to moderation in the overall supply of existing drugs. Consequently, the double-digit price erosion witnessed in the US generics market during the past couple of years should stabilise at high single-digits this fiscal. To also increase exports, large pharma companies are developing higher-margin complex/specialty drugs and introducing new generics which have only recently gone off patent and where competition is moderate. Thus, he predicts US formulation exports may grow 6-8 per cent this fiscal after an extended period of underperformance.

Pharma companies are deploying various strategies to balance out the loss of revenues from the US generics market. Firstly, a focus on RoW markets. CRISIL Ratings expects domestic pharma companies should be able to register 8-10 per cent growth in revenues from RoW markets, this fiscal.

Secondly, pharma companies are increasingly venturing into tender-based, institutional sales and enhancing marketing channels across the globe.

Thirdly, domestic pharma companies are also expanding into new semi-regulated geographies, with a focus on increased market penetration and faster new product launches given less stringent regulatory requirements.

However, CRISIL Ratings analysts predict that domestic companies may not be aggressive in driving growth in select markets such as Latin America, due to high currency volatility and geopolitical risks.

Thus the de-risking of supply chains and revenue models will continue, as pharma companies look for breakthrough deals to explore synergies. For example, JB Pharma, now controlled by private equity firm KKR, is aggressive about brand acquisitions as a key pillar of its growth strategy. (Read more in the story, Betting big on India in the June edition of Express Pharma). Spain’s interest in collaborating with India’s bulk drug plan, should it fructify, is a huge vote of confidence in India’s pharma prowess and talent pool. Let’s hope the industry, and our policymakers, can capitalise on this opportunity.

The post Exploring synergies and de-risking strategies appeared first on Express Pharma.

Mankind Pharma’s successful IPO raises hope for IPO-wannabes but the real hard work starts after the IPO party ends. Most companies face an IPO hangover, with share prices dipping post the IPO as they struggle to meet raised investor expectations. Will Mankind Pharma buck this trend?

Mankind Pharma’s IPO was oversubscribed 15.32 times, thanks largely to qualified institutional buyers (QIBs). The response of retail investors was slightly more circumspect, bidding for 92 per cent of the allotted 35 per cent shares.

In spite of this dampener, Mankind Pharma’s IPO holds out hope to other companies, pharma and non-pharma, planning for their IPOs. But only if the pricing is right and the company’s financials pass muster.

Mankind Pharma ticks all the right boxes. It has a good product mix of consumer and Rx brands with most leading or in the top five brands in their categories. It has a strong differentiated pipeline, proven leadership, healthy CAGRs, etc.

But like most of its pharma peers, it also faces challenges. Regulatory oversight is a major concern, especially as most pharma companies are turning to third-party manufacturers to keep costs down and be more flexible. Pharma companies in India are set to face higher scrutiny, by global as well as national regulators, thanks to recent high-profile cases of violations of good manufacturing practices (GMP).

For instance, the Drug Controller General of India (DCGI) along with state drug control heads, has been on a clean-up drive since March. As per reports, around 200 companies suspected of faulty manufacturing practices are on the radar. 76 pharma companies in 20 states have faced such inspections, resulting in 26 pharma companies receiving show cause notices. Thus the GMP bar will only rise further.

Secondly, increasing price control in the domestic market impacts Mankind Pharma more than some of its peers, as approximately 97 per cent of its revenues (past three years + nine months ending December 31, 2021) are from India. In the latest recalibration of prices of medicines in the National List of Essential Medicines (NLEM), the National Pharmaceutical Pricing Authority (NPPA) has capped the prices of 651 of the 870 drugs listed in the NLEM. While a seven per cent reduction in costs of these medicines is welcome news for patients, this will impact the balance sheets and strategies of pharma companies in India.

Thirdly, while pharma companies in India might benefit from the China+1 policy, companies like Mankind Pharma are still dependent on China and other countries for certain raw materials.

These challenges force smaller pharma companies to cut R&D expenses. Industry reports estimate that five of the top pharma companies in India account for two-thirds of the R&D spends. This is not a good sign as it will translate into a thin product pipeline, with few to none differentiated new products.

This cautious investor sentiment in pharma is also reflected in the recently released India Private Equity Report 2023 from Bain and Indian Venture and Alternate Capital Association (IVCA), titled ‘Trial by fire: Indian PE ecosystem stays resilient in a globally challenging year’. As per the report, pharma was one of the sectors which saw a slowdown in PE activity in 2022.

The Bain-IVCA report points out that the long-term outlook for the pharma sector in India is positive, led firstly by a deep pharma ecosystem with consistent improvement in quality, compliance, reliability and cost. Will pharma companies continue to invest in quality systems and upskill their employees to work on such systems?

Secondly, regulatory enablers are boosting manufacturing, such as PLI 2.0 being expanded to high-value goods, and government investment in bulk drug parks to boost local API manufacturing. Finally, tailwinds from global sourcing diversification, and the opportunity for generics where India has the largest share in global supply by volume, make the sector a long-term bet, as per the Bain-IVCA report.

While Mankind Pharma’s IPO re-validates the long-term potential of the India Pharma Inc narrative, it won’t take much for the story to unravel. Pharma leadership will thus need to strategise carefully on the most efficient way forward. 

The post Why Mankind Pharma’s IPO could be a milestone appeared first on Express Pharma.

The turf war between offline and online pharmacists continues. Many leading e-pharmacies, including Amazon, Apollo, Flipkart, Tata-1mg and PharmaEasy, received show-cause notices in February for allegedly selling schedule H, H1 and X medicines without valid licenses. The trigger was a warning by the All India Organisation of Chemists and Druggists (AIOCD) that they would launch a country-wide movement if the government failed to take cognizance of their concerns regarding alleged malpractices like unsustainable discounts, misuse of patient data, and fake prescriptions. They also allege that some of the online pharmacies do not have valid licences.

This was followed by a PTI report on the revised draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023, which is currently doing the rounds of various concerned ministries. It seems that the group of ministers tasked with reviewing the revised draft of the bill raised concerns with the proposed draft and made changes. While a previous version of the draft bill required permission to operate an e-pharmacy, a revised version reads that the central government ”may regulate, restrict or prohibit the sale or distribution of any drug by online mode, by notification.” Thus, while the previous draft allowed for permission to operate an e-pharmacy, the revised draft bill does not have this clause.

After stepping up and meeting patients’ needs during the pandemic, online pharmacies were seen as a blessing. COVID-19 patients booked and paid online, and medicines were delivered within 24 hours, if not earlier. Discounts were the cherry on the cake. Investments flowed into the sector as India is a nascent market with room for growth in the under-served tier 3/4 towns.

Online pharmacies seem to have come full circle now, attracting the same mistrust as in pre-pandemic times. Ironically, it is discounts that are tripping up the online pharmacy sector. Going by the dictum, that there are no free lunches, discounts do have a downside. Cut-throat competition forces online pharmacies to keep offering deeper discounts, in the hopes of poaching/attracting and retaining more customers from rivals. This soon became a race to the bottom, with eroding profits of online pharmacies.

The discounts given by online pharmacies cause a lot of heartburn among traditional chemists as they wean away customers, forcing smaller chemists to either shut down or sell out to national chains of online chemists.

Patients too are realising the flip side of discounts. They are never sure how much of the health data they share is being kept confidential. Secondly, they suspect online pharmacy staff push unnecessary medicines, and expensive supplements. Many patients have complained that they try to upsell them to brands giving higher margins, as they are incentivised and need to meet high sales targets.

For their part, online pharmacies say that they are open to audits as they have already enough safeguards in place. Global PE investors in online pharmacies too are worried that their investments will go down the drain if the ban comes into effect. Many have reportedly sought meetings with the Commerce Ministry to explain their stance, reasoning that they partner with registered offline pharmacy stores with qualified pharmacists to dispense medicines against validated prescriptions.

For example, Devashish Singh, Co-founder and CEO of MrMed, an online pharmacy for super-speciality medicines, reiterates the stance of most e-pharmacy players, saying that MrMed welcomes laws governing e-pharmacies and hopes that these will be drafted keeping patients’ well-being first. He points out that today, there is no definition of an e-pharmacy/online pharmacy under any law in India and this needs to be defined.

Underlining the benefits of online pharmacies, he states that MrMed delivers to thousands of towns in India where the availability of medicines that help patients fight cancer, HIV and other life-threatening conditions, is limited. This access to speciality medicines in smaller towns is an important factor amongst a host of others that should be considered in the eventual release of regulations. Singh also hopes that these regulations, amongst other things, will also help address concerns related to data privacy, malpractices, and other issues that have been raised previously. He says his company is looking forward to working closely with regulatory authorities to ensure that their services meet all requirements.

Enforcing regulations has always been difficult, so is a ban on online pharmacies the only foolproof answer? At an industry level, the government is also bound to realise that this ban might hurt many start-ups in the sector and increase unemployment. At a policy level, it might send the wrong signals to global investors.

The rollback of unconditional support for online pharmacies during the pandemic could be criticised as indecision and policy paralysis of regulators. But it is actually sound governance. Tougher regulation, tighter rules will ultimately serve the Indian patient better in the long run. Weeding out unscrupulous online pharmacies will ensure a more ethical, trustworthy sector, with more sustainable revenues.

This is a storm that has been brewing for quite a few years. It is time all stakeholders get together, share concerns and find a middle path, keeping patient/consumer interest as the top priority.

The post Will online pharmacies blink off in India? appeared first on Express Pharma.

In a sign of the times, 10 of the top 15 companies receiving the highest number of ANDA approvals in 2022 are Indian. An analysis of 2022 ANDA approvals shows that Indian companies once again dominated the ANDA approvals, with 355 or 48 per cent of total ANDA approvals. This further improves their share from 42 per cent (267 approvals) from last year, a 33 per cent growth of ANDA approvals for Indian companies versus 2021. India was followed by the US, China, Europe, and Israel, in that order, in the number of ANDA approvals.

The analysts, Meenu Grover Sharma, partner, Business Associar Consultants and Dr (Prof) Harvinder Popli, Director, School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences & Research University further point out that 42 per cent of first-time-generic approvals and 38 per cent of Competitive Generics Therapies (CGT) approvals were garnered by Indian companies. This was close to the score by US-based companies, which received about 50 per cent of all CGT approvals and 21 per cent of first-time-generic approvals.

The authors conclude that significant filing costs of almost a quarter million dollars per ANDA, increasing programme fees, and continuing pricing pressure with increasing competition have not dampened the interest in participating in the US generics space, especially for Indian players.

Moreover, over 11 per cent (86 of 742) ANDAs approved this year (including nine ANDAs approved through the CGT route) are already listed as discontinued, driven by the FDA guidance to notify significant disruption in availability or permanent discontinuation. Going by the trend observed in previous years, the authors estimate that if 18 per cent of this year’s ANDAs are discontinued by next year, it would represent approximately $32 million of sunk cost across all companies.

The question is, will companies look at reducing ANDA filings to curtail sunk costs? Or will the FOMO factor (fear-of-missing-out) continue to drive ANDA filings as a strategic competitive necessity?

The ANDA approvals also indicate that India, except for Biocon/Viatris, do not feature in biosimilar filings. Similarly, oral formulations dominate the ANDA filings from India (69 per cent of approvals) with little less than 20 per cent coming from injectables. The ratio is reversed for arch rival China (69 per cent injectable products and 26 per cent oral formulations.) These trends could represent missing links in India’s therapeutic offerings, which will need rectifying in the years ahead.

While India tops the list of ANDA approvals for the US market, it is near the other end of the US Chamber of Commerce’s International IP Index. Which is another sign of these times. India maintains a fairly low ranking of 42 out of 55 countries in 2023 International IP Index report, with the innovation score remaining unchanged from 2021 at 38.64 per cent.

The IP Index lists various weaknesses of India’s IP ecosystem, with the dissolution of the Intellectual Property Appellate Board in 2021, combined with the ‘long-standing issue of an under resourced and overstretched judiciary’, leading the list. India’s ‘limited framework for the protection of biopharmaceutical IP rights’, lack of regulatory data protection or patent term restoration for biopharmaceuticals and ‘lengthy pre-grant opposition proceedings’ are also cited. India’s first and only compulsory license granted way back in March 2012 for ‘commercial and nonemergency situations’ still figures as a weakness area as does ‘limited participation in international treaties.’

The IP index report does acknowledge some of the country’s areas of strength and measures deemed IP friendly, like ‘generous R&D and IP-based tax incentives’, and the fact that the country is a ‘global leader on targeted administrative incentives for the creation and use of IP assets for SMEs.’ It also mentions that there have been ‘strong awareness-raising efforts regarding the negative impact of piracy and counterfeiting.’

India’s dominance of ANDA approvals juxtaposed with the continued low ranking in the US Chamber of Commerce’s International IP Index signals that any tweaks in India’s IP regime will be for the country’s benefit and not overtly influenced by diplomatic and trade pressures. India will continue to forge its own IP policy.

Thus the country continues to be a very vocal advocate for the proposal to waive IP rights for COVID vaccines and diagnostics, not just COVID therapeutics. Conversely, the IP index cautions that these negotiations with the World Trade Organization (WTO) and World Health Organization (WHO) to waive IP rights ‘will undermine the innovation ecosystem that was pivotal to combatting COVID-19 and threaten the ability to respond effectively to the next major global public health threat.’ Balancing market expansion strategies with IP policy will remain a recurrent theme for India pharma for the foreseeable future.

The post Top of ANDA approvals list, low on IP index appeared first on Express Pharma.

As Union Budget 2023 was Finance Minister Nirmala Sitharaman’s last full ‘parting shot’ budget before the general elections next year, the life sciences industry hoped that many of their long-standing demands would get addressed.

Comparing the pharma sector’s laundry list of expectations to the announcements made, the industry’s recommendation for R&D-related support seems to have been met. But while the industry has lauded the announcements on R&D (https://www.expresspharma.in/union-budget-2023-industry-lauds-focus-on-rd/) the mood is cautious optimism, as leaders await the fine print.

At best, the proposal to set up a new programme to promote research and innovation through centres of excellence, extending collaboration with the ICMR laboratories, encouraging investment in R&D, signal that the government understands the importance of supporting an ecosystem for the further evolution of India’s pharma sector beyond the pharmacy of the world. Pharma R&D in India so far has focused on the D, can we shift focus to the R? Maybe it is an attempt to position India as an attractive global pharma research hub, not just as a global manufacturing hub.

But much more will have to be done for this transition to happen. Will this announcement lead to a Research Linked Incentive (RLI) scheme? The fact that there was not much relief provided on the demand to increase tax deductions on R&D spends, is discouraging, underlining the fact that the path to R&D remains narrow and needs deep pockets. If the government can work on making the R&D policy more transparent, we could see investments in pharma R&D flow into India.

The rationale for an RLI is that without a strong research core, the existing Production Linked Incentive (PLI) programme will miss the opportunity to add long-term value to the sector. Many pharma companies are already cutting back on research spends in real terms, discouraged by the slow pace and lack of results. Some comfort comes with the recent Q3FY23 results of pharma companies in India, with domestic formulations remaining a bright spot, with a double-digit year or year growth potential, despite low-to-nil COVID-related revenues this quarter. However, the United States (US) revenues continue to disappoint, with flat growth.

But more importantly, quality concerns continue to dog the sector. Be it data integrity-related 483s from the US Food and Drug Administration (USFDA), Nepal’s drug regulator alleging non-compliance to WHO norms or WHO alerts on cough syrups with deadly ingredients. Non-resolution of such regulatory raps, as well as volatile prices of inputs and increasing price control, remain the key risk factors for India’s pharma sector.

Let us hope that the new infrastructure being built is future-ready, with investments in greener technologies/ techniques/ingredients. While pharma honchos have no control over prices of raw materials (except to put in place more resilient procurement practices) and price caps (besides sending representations to policymakers), they can definitely influence stricter enforcement of compliance to GMP norms, data integrity practices, etc. at all their premises. Training of employees to comply with evolving global guidelines should be the overall goal for 2023.

Can policymakers link budgetary allocations to better quality compliance, with stricter oversight? This would serve multiple purposes. Firstly, patients would be assured of safer medicines at affordable costs, with minimal environmental impact. And, secondly, higher quality standards at affordable prices would serve as a formidable competitive advantage and set the bar higher for any future contenders for India’s ‘Pharmacy to the World title. Can we see policymakers and industry leaders double down to this task in 2023?

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The more things change, the more some things remain the same. China could be in for another COVID wave in 2023, thanks to a zero-COVID policy that misfired. But, inspite of having enough warnings over the past two COVID years, India Pharma Inc seems to be heading for another shortage of key chemicals used in the manufacturing of medicines. Ranging from Key Starting Materials (KSMs), intermediates and APIs, will India once again face stockouts and spiralling medicine prices? Or, have previous supply shocks helped immunise our pharma procurement systems?

API factories in China could remain leanly manned due to ill health of staff or lockdowns. The Chinese government has reportedly moved to reduce exports of KSM/API/intermediates, seeking to stockpile medicines for its own population should the COVID cases increase. As a result, certain imports from China have already seen price spikes.

It is but natural for governments to safeguard their citizens first. India did the same during the COVID vaccination drives when vaccine makers were restrained from exporting vaccines until India’s population was sufficiently vaccinated.

On cue, tensions at the India-China border have also risen, as we head into winter. And, as China has stopped reporting daily COVID cases, there is no way the world has accurate information or insights on how the country is coping with the virus.

There are already warnings of the weak links in the pharma procurement chain. Reports suggest that 90 per cent of India’s antibiotics are still sourced from China. Some progress has been made, but these will take time to mature. For instance, 51 companies have projects approved under the Production-Linked Incentive (PLI) scheme, which was launched in July 2020. But, to date, just around 25-30 per cent of these pharma companies have started projects. These units are set to start manufacturing operations only by 2023-24, meaning that they are more than a year away from making any meaningful contributions.

Pharma manufacturers blame the slower-thandesired takeoff of the PLI scheme on the convoluted process of getting approvals from multiple departments to start a pharma plant. This is understandable as the pharma sector does have a huge pollution problem and green manufacturing processes are more expensive.

Will China’s COVID wave of 2023 serve to re-double efforts of India’s policymakers and pharma makers to tackle these roadblocks? Beyond bagging a larger share of the global move to relocate manufacturing units out of China, India’s pharma and allied companies have also made plans to diversify beyond China to Europe and other locations.

Fortunately, companies which heeded the writing on the wall, much before COVID, are already in a better place. For instance, according to Manoj Mehrotra, President-Pharmaceuticals, Hikal, the company’s efforts to be self-sufficient are finally bearing fruits. He explained that over the last two to three years, they have been looking at partners within India and other geographies that are not dependent on China. Though they are currently dependent on China for about 50 per cent of their KSMs, they intend to bring it down further in the next few years.

But, companies like Hikal cannot rest on past successes and will have to be constantly vigilant. Tweaking their strategies as per evolving geo-political events will be the norm rather than the exception. For instance, Hikal’s plans to source some chemicals from Eastern Europe suffered a setback due to the escalating energy prices and the instability of the Ukraine-Russia conflict. Even so, Mehrotra reiterates that their long-term plan, the objective is to have a robust supply chain out of India and Europe and reduce dependence on China.

India has several companies like Hikal that are vying to be vital cogs in the global lifesciences procurement value chain. Though changing gears may initially be painful, if executed right, the gains are manifold. For instance, in Hikal’s case, validation of its strategies can be gauged by deals like its multi-product 10-year contract for APIs with a global pharma company as part of the client’s supplier consolidation programme. Mehrotra indicates that there is a fair chance that they may get a few more (APIs) in the next wave of consolidation. I am sure we will get to hear more such success stories as pharma companies in India find their sweet spots.

Mehrotra echoes the views of most pharma honchos that there is a lot more that can be done on the policy front. As one example, alluding to the performance of the PLI scheme, he mentions that multi-national customers feel that in India, the environmental clearance process is slow and suggests that the government should consider giving category-wise rather than product-wise approval to various manufacturing industries. One hopes that the evolving situation in China is cause enough for India’s policymakers to critically analyse such approaches, while ensuring that the companies meet the global norms for environment protection and effluent treatment, etc.

If we do see a COVID wave in 2023, with some countries seeing similar infection rates following China’s lead, it is another timely warning to re-focus on procurement strategies and make supply chains more resilient and agile, besides relocating to more transparent and stable regimes. The good news is that India fits the bill. The bad news is that so far, the sluggish rollout of the PLI scheme in an important priority sector like pharma does not inspire too much confidence. Let us hope that 2023 is a true watershed year for proactive and strong pharma policies, starting with Budget 2023, which are industry-friendly, but also balance other compliance norms expected of a global corporate citizen.

viveka.r@expressindia.com
viveka.roy3@gmail.com

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Authorities from The Gambia’s Medicines Control Agency have now seemingly back-tracked on their initial allegations linking Haryana-based Maiden Pharma’s cough syrup to the deaths of 70 children from acute kidney injury.

A Reuters report dated November 2 quotes Tijan Jallow of The Gambia’s Medicines Control Agency, saying, “We haven’t concluded yet it is the medicine that caused it. A good number of kids died without taking any medications.” There are reports of children in Indonesia dying from similar kidney injuries, linked to the use of paracetamol syrups.

While we wait for more clarity and the final reports of the investigation, an office memorandum dated October 27 from the Drug Controller General of India, VG Somani, announced the setting up of a seven-member panel to prepare India’s ‘National Drugs Database.’

Explaining the rationale for such a move, Somani said that such a database is “crucial” for “not only empowering consumers but also improving the monitoring mechanism for quality of drugs in circulation across the country and uniform administration of the regulatory system.”

Over the next three months, the seven-member committee will “examine the existing database available with various authorities like States/UT Drug Control Department, various manufacturers, marketers, importers.”

The Committee is expected to give its recommendations and prepare a comprehensive National Drugs Database for drug formulations manufactured/ marketed in the country. It will provide detailed information on the drug, its dosage form, strength, and details of the manufacturer, marketer or importer of the drug, as per the office memo.

AK Pradhan, Joint Drugs Controller of India, will be the convener of the panel. Other members of the panel include Dr Hemant Koshia, Commissioner, Food and Drug Control Administration (FDCA), Gujarat; Dr Pooja Gupta from AIIMS, New Delhi; Dr Jerian Jose, scientist at the Indian Council of Medical Research, New Delhi, DR Gahane, Joint Commissioner of Food and Drug Administration (FDA), Maharashtra; BT Khanapure, State Drugs Controller, Karnataka, and Navneet Marwaha, State Drugs Controller, Himachal Pradesh.

Dr Koshia reveals that some states with major pharma hubs, like Gujarat and Maharashtra, have already developed their own databases independent of each other and the centre. Now, the task is to decide on the best template and merge these databases seamlessly.

Gujarat, for instance, uses an online drug licenses database, developed with NIC, since 2012-13. With information on all drug manufacturing licenses literally at his fingertips, Dr Koshia recounted how the database gave him an almost instant idea of the stocks of Hydroxychloroquine (HCQ), with both API and formulation makers, during the pandemic. He had a list of manufacturers from his state within minutes and was able to contact them within an hour, requesting them to stop exports till the country’s needs were met. He was ready with names of manufacturers within his state and their inventory levels when the authorities called him to give an idea of HCQ stocks within the state.

The plan, according to Dr Koshia, is first to catch the low-hanging fruit, i.e. link up the major pharma-producing states, like Gujarat, Maharashtra, Andhra Pradesh, Goa, Himachal Pradesh, Uttarakhand, etc as fast as possible to a national drugs database, co-developed by NIC and CDAC, which would cover almost 80-90 per cent of the country’s drug production. The other states will be added in due course of time, after adequate training on the software, etc.

Forming a national drugs database is a very welcome announcement, and it is impossible not to view it as learning from The Gambia-Maiden Pharma case. One wonders why it wasn’t attempted earlier, or if earlier attempts were not successful. However, better late than never.

Irrespective of whether the children in The Gambia and Indonesia died after consuming Maiden Pharma’s products or not, it is important to trace out the probable reasons for these tragic deaths. If any of the products have higher than acceptable levels of diethylene glycol (DEG) and ethylene glycol, then this needs to be rectified.

The children in The Gambia could have died of ‘underlying causes’ or pre-existing health conditions. As the country’s most recent official statement mentions, it’s now coming to light that many children who died reportedly did not consume Maiden Pharma’s syrup, while others went on to survive despite consuming the product.

With the growing realisation among global regulators that the presence of novel nitrosamines is more widely spread than previous estimates, regulators will have to reconfirm what daily levels of DEG are acceptable. This is an evolving problem and it could take time to understand all the technical aspects.

Regulators can only remind the industry of existing guidelines designed to detect such impurities. For example, an October 7 letter from Dr Rajiv Singh Raghuvanshi, Secretary-cum-Scientific Director, IPC, to the DCGI pointed out that the commission has developed 1000 Indian Pharmacopoeia Reference Standards (IPRS) and impurity standards for the quality testing of drugs. Somani urged pharma manufacturers to use the IPRS to ensure their manufacturing facilities maintained the quality of drugs.

The question remains, what are the plans to enforce such regulations more stringently? It is 36 years since glycerine contaminated with DEG was linked to 16 deaths in Mumbai’s JJ Hospital. The case continues, with the accused yet to be brought to book. The case was the first time DEG was linked to deaths and for a while, impurity testing took centre stage.

Clearly, we let down our guard too soon. Today, even more is at stake. Hopefully, initiatives like the National Drugs Database incorporate the lessons learnt. Equally, if not, more importantly, manufacturers need to man up and stop cutting corners hoping that the law will never catch up.

viveka.r@expressindia.com
viveka.roy3@gmail.com

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