In a move aimed to ensure quality generic drugs, the Union Health Ministry has made bioequivalence studies or stability testing mandatory for certain class of generic drugs manufactured in the country. Incidentally, the Ministry had rejected a similar proposal five years ago, when the UPA was in power.
The Government is pushing generic drugs in a big way to cut down the expenditure cost of the poor patients on purchase of medicines.
Moving towards this direction, the Ministry had advertised the draft amendments in early February for public comment and then formally amended the Drugs & Cosmetics Rules, 2017 through a notification on April 3 to incorporate the change, making the bioequivalence studies on generic drugs a must.
A generic drug is identical — or bioequivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
Prime Minister Narendra Modi too had last month announced plans to bring in a law to compel doctors to prescribe generic drugs.
Union Health Secretary CK Mishra said that the step aims to ensure quality drugs in the market as now and then questions were being raised about their efficacy. He also said that all the State drug controllers have been asked to tighten the generic drug system and enhance vigilance to ensure that only quality generic medicines are sold in the market.
Mishra further said that the States have been advised to ask the doctors to prescribe generic drugs to patients and write the name of the salt and not the brand name under which the salt is manufactured and marketed.
The Medical Council of India (MCI), an apex body that supervises medical education in the country, already has a recommendation in place wherein doctors have been advised to preferably prescribe generic drugs.
Incidentally, in 2013, the Dr Ranjit Roy Choudhary expert panel had specifically recommended that such studies be made mandatory for all generic drugs sold in the Indian market.
However, the Drugs Consultative Committee (DCC) of the DCGI had turned down the recommendation, while at the same time suggesting that such testing be performed for exports to foreign countries in order to pre-empt any concerns regarding quality, said public health activist Dinesh S Thakur and advocate Prashant Reddy in their report on ‘fixing India’s broken drug regulatory framework’ released in June last year.
Reddy said that the “challenge for the future will be to ensure that clinical research organisations that conduct bioequivalence studies do not commit fraud. This is a daunting task given the list of organisations that have been caught red-handed by foreign regulators.”