Generic drugs have been in the limelight after Prime Minister Narendra Modi announced that the government will make it compulsory for doctors to prescribe generic drugs. The present BJP-led government does not shy away from taking bold steps or reforms in various sectors. Be it economic reforms like GST and demonetisation, the current government’s sheer courage and determination are praiseworthy.
The issue of compulsory prescription of generic drugs instead of branded counterparts has been a contentious issue among the medical fraternity. To understand this better, let’s first discuss what a generic drug is. According to WHO (World Health Organisation), “A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights.” To illustrate better, a term coined by Oxford dictionary perfectly suits the discussion, “Not protected by trademark registration; Nonproprietary or any product, as a food, drug, or cosmetic that can be sold without a brand name.”
What differentiates the discussion from the definition is the perspective of various factors concerning the topic. In India, the issue of generic drugs vs branded drugs is grounded on the basis of larger societal good i.e. affordable healthcare. Branded drugs tend to be more expensive, and given the fact that a huge part of the population lives below the poverty line. Affordable medicines take the centre stage in policy discourse. The larger issue that unfolds over here is not of pricing, but of the status of the quality of generic drugs.
Various health reports and journal have commented on the poor quality of Indian generic drugs. Lancet Health Journal has carried out an article which stated that “generics drugs sold in Africa by some leading Indian drug manufacturers are of substandard quality compared with the same drugs that the companies distribute for selling in India and non-African countries.”
The allegations are not concocted but it is evident from various reports and studies within India itself. A 2017 report from the Comptroller and Auditor General’s office had revealed anomalies and substandard qualities of generic drugs at several hospitals. The figure is startling to observe, more than 32% of defence drugs supplied to armed forces were substandard. The Government of India’s own survey on the quality of drugs in the country also shows not of standard quality (NSQ) for 10% of all drugs sourced from governments.
Generic drugs have the same effect as innovator i.e branded drugs. The US and the European Union have stated that generic drugs are equal to the innovator drug by making bioequivalence (BE) testing compulsory. This implies that for any generic drug to be sold, it needs to be tested. According to a report in The Hindu, this means that “generic formulations on healthy volunteers are tested so as to ensure that effectiveness of the generic drugs through physiological characteristics is the same as their innovator counterparts.”
Currently, India’s pharmaceutical industry has different policies concerning the sector. State and central governments have multiple powers and stakes in it. The regulation of manufacture, sale, and distribution of drugs is primarily the domain of state government whereas central government authorities deal with the approval of new drugs and clinical trials along with laying down the standards for drugs, control over the quality of imported drugs are with the central authorities. However, the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare is one of the most important agencies dealing with all drug-related issues in the country.
Issues like quality will play an important role in the prescription of drugs by medical practitioners. Research reports have documented that heat and humidity play a major role in the failure of drugs in government-run health centres.
Another concern about generic drugs has been that not much has been done on improving the drug testing laboratories at central and regional levels. Currently, the nodal agency i.e. CDSCO is grossly understaffed to perform its duties across the country.
Standardisation of formulas is required. Many a time, one can see that generic drugs are not always identical to brand drugs and it may worsen a patient’s health. There are just too many things that are involved in this debate.
The policy concerning compulsory prescription of generic drugs is a well-intentioned policy for larger public good, but the reality of generic drugs has been of controversies and allegations. Only 1% of all generic drugs sold in India undergo the good quality test that is practised in developed countries. Confidence building measures are the need of the hour with the cleaning up of regulatory bodies. Until then, market forces will take their own way.