Following the recent announcement by PM Narendra Modi hinting at a legal framework for doctors to prescribe generic medicines cheaper than equivalent branded generic drugs, doctors appeared to welcome the move and opined that it will benefit patients as the life-saving drugs could be obtained at much cheaper rates. (1,2)
In reality, India being the largest supplier of generic medicines globally (20% of global export volume); the quality of the generics should not be an issue. Generic drugs dominate India’s pharmaceutical space, wherein generics account for about 70% of the market. Also, India accounts for approximately 30% (by volume) and about 10% (value) in the US$ 70-80 billion US generics market. Therefore, quality of the manufacturing has got nothing to do with branding. It is purely a manufacturer’s decision and ability enforced by law which is paid for by the customer. (3)
However, PM Modi did attract the wrath of many following the announcement. This is because a lot of doctors questioned the accessibility and quality of the generic drugs. However, many feel this to be just an excuse, as doctors fear that this move would upset their nexus with the drug companies. (4,5) Furthermore, industry associations reaching out to the health ministry, hoping to approach the PMO to prevent the law from being passed, were opposing proposal on the grounds that the onus of decision-making (what patients should consume) would shift from doctors to chemists. This group further pointed out that the chemists are unregulated and have no ethical or commercial obligation on what they sell patients. However, the Ministry of Health and Family Welfare announced to seek only qualified candidates in the workforce. (6)
Consequently, the health ministry has made bio-equivalence (BE) studies mandatory for all drug manufacturers before launching any generics in the market. This is primarily to guarantee the same quality and efficacy of generics as their branded counterparts. The health ministry has also issued a gazette notification to this effect. (7)
Frankly, this move is worth applauding for, since it will ensure the quality as well as appropriate distribution of the generic drugs. This is because most of the doctors have been avoiding generic prescriptions in the name of lack of quality; while actually focusing on the incentives from the pharma marketing.iv On the other hand, in reality, prescribing generics would only benefit the patient in terms of both quality and affordability. But going by certain decisions the government has made since last couple of years, we can surely say that India has started accepting the patient-centric healthcare model.
Big pharma players and even the smaller (generic manufacturers) ones need to think of ways to rebrand themselves. Certainly, not every company can manufacture a drug for every possible disease condition; however, the future of pharma business is predicted to go by branding based on robust ’therapy area’ leadership. For instance, Mylan Pharmaceuticals, the biggest generic drug manufacturers globally, has been manufacturing more Parkinson’s medicines than any other company in the world. (8) Furthermore, small players will have to invest money in proper and ethical ways of marketing, i.e. publishing results from BA/BE studies to prove the similar efficacy of generics with reference to their branded counterparts. (9)
It has always been a patient-centric approach. The solution to all these complications is ‘patient empowerment’. Doctors primarily make diagnosis; they cannot polarize patients to earn their own incentives from the pharma players. Also, learned chemists/pharmacists should hopefully provide patients with cheaper generics. In the end, it is patients who must choose what is right for them.
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