East Delhi resident Gaurav Kumar has entirely shifted to Jan Aushadhi Kendras for medicinal needs. He unequivocally dismisses doubts over the quality of drugs sold at the Centre-run kiosks. “The price difference is also whopping, 50-90 per cent,” he says. Anil Vats, a retired government servant from Ghaziabad, says: “My lung disease tablets cost Rs250 per pack. At Jan Aushadhi, I get it for Rs60.”
To ensure quality, all batches supplied to over 10,000 Jan Aushadhi stores across 750 districts go through double checks. Ravi Dadhich, CEO, pharmaceuticals and medical devices bureau of India, ministry of chemicals and fertilizers, tells THE WEEK: “After procuring medicines from WHO GMP (Good Manufacturing Practices) certified suppliers, each batch is again tested at our laboratories to ensure quality.”
Certainly, these stores are striving to provide affordable generic medicines. This, however, is only a small part of the story. The ecosystem of generic drugs in India is far too wide and cumbersome. Generic or branded medicines have no specific definitions. They, for all purposes, generally “contain the same active ingredient in the same dosage form, intended to be administered by the same administrative route” as the branded drugs.
Dr Preeti Kumar, vice president, public health system support of the Public Health Foundation of India, explains: “There are primarily three types of drugs―generic, branded-generic and patented.” She adds that the generic and patented together constitute around 20 per cent of the market. “The remaining 80 per cent is covered by branded-generics that constitute around 2,800 formulations and unique molecules for various diseases spanning over 55,000 brands,” she says. “If we keep the patented drugs aside (which is only 8-10 per cent), the issue of quality remains with both generic and branded-generics and it is not entirely correct to equate branded-generic with quality.”
Dadhich adds, “The generics sold under a brand become branded-generics.” By numbers, the labyrinth is even more gigantic―India is the biggest exporter of generics to around 200 countries. The top five importers are the US, Belgium, South Africa, the UK and Brazil. More than 60,000 generic drugs are produced in India across 60 therapeutic categories. India's drug and pharmaceutical products exports grew by 125 per cent from Rs90,415 crore in 2013-14 to Rs2.04 lakh crore in 2022-23. “These constitute 5.71 per cent of the total exports and ranks third worldwide by volume,” according to the ministry of health and family welfare.
Domestically, the market reach in India is to the tune of Rs1.5 lakh crore. The enormity of the sector speaks volumes about the inadequacy of all government schemes put together in making medicines affordable, accessible and acceptable to all.
Understandably, therefore, the doctors were up in arms over a government order making it compulsory to write generic names on prescriptions. Although existing rules do exhort physicians to prescribe drugs with generic names, the mention of penalties for non-compliance and potential licence suspension in the August 2023 order took the doctors by surprise. Their vociferous opposition forced the government to put the directions on hold within two weeks. At the heart of the doctors’ opposition was the uncertainty over quality of generic drugs.
“The government is sensitive on the issue and understands,” says Sharad Aggarwal, president of the Indian Medical Association, which led the resistance. “That is the reason they reversed the decision. Spurious drugs is a national issue and all of us will have to show maturity in handling the situation.”
The doctors’ apprehensions are not misplaced. A recent study by the Postgraduate Institute of Medical Education and Research, Chandigarh, attests to the substandard quality. In the study, published in an international journal, subjects given a patented (innovator) drug achieved better therapeutic levels than those administered the generic counterpart.
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Dr Rahul Singh, head of critical care unit, Yathartha Hospitals, concurs with the findings of the study. “Certainly, the efficacy and blood levels will differ in case of generic medicines and innovators,” he said. “In case of generic drugs, the standards and optimisation is not validated so the results are compromised.”
This issue acquires additional significance as the WHO says that generic products must satisfy the same standards as innovator products. Legislatively, the rules in India forbid malpractices in manufacturing of drugs. Pharmaceutical companies claim that apart from compliance necessities, the risk to reputation leads brands to meet global standards. “To ensure quality of medicines sold under brands, companies adhere to rigorous quality measures,” says Nikkhil K. Masukar, CEO, Entod Pharmaceuticals. “They conduct thorough testing, follow GMP and comply with regulatory standards to guarantee the safety and efficacy of their products. Brand reputation is often built on a commitment to delivering high-quality medications, and companies invest significantly in maintaining these standards.”
Dr Rajeev Sood, vice chancellor of the Baba Farid University of Health Sciences, Faridkot, Punjab, says that while the guidelines are ideal, the problem lies with the implementation. “There is no set mechanism to monitor the quality of generic medicines,” he says. “Batch by batch, the quality is different.” Dr Girish Mathur, president of the Association of Physicians of India, adds that there is a pressing need to put mechanisms that ensure quality.
Aman Gupta, managing partner, Health Practice Asia Lead, Spag Finn, a Gurugram-based consultancy firm, says common assurance needs to be provided on quality, efficacy and safety. “In recent times, questions have been raised on manufacturing practices and quality standards of Indian drugs (specially generics), not only within India but at the global level,” he says.
Insiders reveal that the quality erodes as a result of manufacturing and market imperfections. “The problem arises when the approval procedures are sometimes compromised because of corruption at multiple levels,” says an employee of a leading pharmaceutical company, who requested anonymity. “The minuscule levels of monitoring of the samples add to the woes and the sub-standard quality reaches the market.” He adds that Indian generic manufacturers start compromising on the quality to sell on lower costs engendering “camouflaged competition”. “The quality is majorly compromised when it comes to the huge domestic market and exports to developing markets such as Africa, West Asia and East Asia,” he says.
The IMA had recently pointed out that less than 0.1 per cent of the drugs manufactured in India are tested for quality. Multiple alerts from the WHO on sub-standard quality of Indian cough syrups in the wake of a number of overseas deaths linked to India-made drugs in countries like the Gambia, Cameroon and Uzbekistan is a case in point. However, that is not the case with exports to developed countries. The stringent regulatory systems and authorities in western and European institutions like the US Food and Drug Administration and European Medicines Agency make it risky for the manufacturers to export inferior quality.
The impediment to ensuring quality, especially for domestic consumption, experts believe, is the ever expanding gulf between demand and the requisite infrastructure, expertise and finance. “Every product should be checked,” says Sood. “But, we do not have the wherewithal to monitor effectively. We do not check where the raw material has been sourced from, there are no proper labs for testing.”
An important factor, according to Kumar, is that India has a federal structure and health is a state subject. “The regulation is also done by state drug control organisations,” she says. “Therefore, it becomes important that states also make adequate budgetary allocations to pick samples and send them to laboratories for testing to ensure quality. Both generic and branded-generic drugs are same in dosage form, chemical strength and quality checks. However, some are directly marketed through prescribers and pharmacies and in some cases the quality of the medicine is associated with the degree of regulation.”
Doctors also blame pharmacies for the bad quality. “It should not only be about controlling doctors but also about controlling the pharmacies,” Sood points out. “Pharmacists manufacture their own medicines and sell them in large numbers. There have also been instances when certificates have been sub-let, thereby exploiting the guidelines.” Aggarwal adds that the move to prescribe generic names gives more power to pharmacists, who may give the medicine which suits their interests and may not align with patients' interest.
There is unanimity on the urgent need to have a “centralised” and a more “proactive” system of testing to make safe and affordable medicines available to all Indians. Says Kumar: “The regulatory investment will have to be commensurate with the quality of the medicines. Best practices at all three levels―procurement, testing and regulation ―will have to be extended to a much wider base to ensure quality medicines reach the market.”
The government’s efforts to strengthen regulations and promote generics are lauded by a few. “Generics have to be the way forward,”says Priyadarshi Mohapatra, founder and CEO of Curebay, promoting e-clinics in rural Odisha. Adds Dr Sujit Chatterjee, CEO, L.H. Hiranandani hospital, Mumbai: “By advocating the use of generic drugs, the government is promoting an environment in health care that respects accessibility and affordability.”
Kumar also agrees that the government is really upping the regulatory mechanisms to ensure only quality drugs come into the market. Aman Gupta praises recent steps by the Drug Controller General of India, including implementation of QR codes and the decision to overhaul drug regulations. He considers work towards framing the Drugs, Medical Devices, and Cosmetics Bill “a crucial step towards upgrading and streamlining the regulatory framework.”
In late December, 2023, the Union health ministry notified its new Good Manufacturing Practices for pharmaceutical products. The new rules facilitate major changes in ensuring quality and categorically hold senior management of the manufacturing companies responsible for quality. The new guidelines are seen as a step in the right direction to elevate the quality of drugs to global standards.
Says Dr Viranchi Shah, national president, Indian Drug Manufacturer Association, “The new rules will of course make a difference in aligning more with the WHO standards and is a welcome step in upgrading the sector.” However, he suggests that a larger window could be given for transitioning, especially to the small industries. “We should engage with small and medium enterprises, handhold them and help them become a part of the envisaged new normal,” he says.
Reiterating the IMA’s stand on introducing “one drug, one quality, one price system”, Aggarwal says, “Why not subsidise the health sector the same way as other sectors are subsidised? The government should do away with this differentiation of generic, branded, non-branded and find a permanent solution to this problem.”
While the government’s intentions to ensure quality is apparent, how much the rules are going to match the monitoring on the ground to make Indian drugs risk-free remains to be seen.