Prescribing generic drugs only the first step, long way to go

Prime Minister Narendra Modi’s statement on getting doctors to prescribe medicines using their generic names may have put the issue of generic medicines on the centre stage.

But away from the public eye, work is already underway at the Union Health Ministry to roll out a regulatory framework to ensure that generic names get greater prominence than the brand names of medicines in terms of labelling and prescriptions. While the move has brought cheer to patients, pharma industry representatives caution that the system is not without pitfalls.

The Health Ministry had initiated a discussion on promoting generic drugs late in March, Joint Secretary KL Sharma told BusinessLine . And the proposals include asking manufacturers to ensure labels that carry generic names of medicines in a font size much larger than the brandname, he said.

The enforcement of quality and manufacturing will be done by the Drug Controller General of India (DCGI) and the Medical Council of India (MCI) will keep a watch on the doctors, Sharma said. In fact, the MCI has amended the regulation last year mandating doctors to prescribe using the generic name to ensure a rational prescription and use of drugs, he added.

Responding to a key concern that prescribing generic names could shift the “decision making” from the doctor to the retailer or chemist who may not understand the scientific rationale or have the best interest of the patient in mind, Sharma said, these concerns would be addressed once the feedback process gets completed.

Drug Controller GN Singh pointed out that the labels of single ingredient medicines have already been mandated to carry the generic name more prominently than the brandname. In fact, the Jan Aushadi shops are also part of the Government’s efforts to promote generic medicines.

The US Food and Drug Administration defines a generic drug as identical or bio-equivalent to a brand name drug in dosage form, safety, etc. These medicines are usually much less expensive than the original branded medicine.. And the explanation for this is that it factors in the cost of research to bring out an innovative medicine. India though is peculiar, in that it is largely a generic drugs market and yet companies differentiate their products through brandnames that command higher prices.

Speaking for the Indian Drug Manufacturers’ Association, Daara Patel said that as drugmakers they would make generic or branded medicine, as required. However, he said, “brands have been developed over the years and doctors and patients develop confidence in them.” Doctors prescribe them based on the experience of patients and feedback received, he added.

“Now chemists will decide, maybe based on the margins they get. They are not competent to judge the efficacy, feedback etc and this will not help patients as reduced prices may not be passed on to the patients,” Patel cautioned.

CM Gulati, Editor with drug journal MIMS, felt the move to ensure generic prescription is difficult to enforce as half the medicine market, is made up of combination drugs (with more than two ingredients), for example. Efforts have been on since the 70s to get doctors to prescribe generic medicines. Such initiatives can have an unintended fallout, say if a chemist gives the cheapest drug with questionable quality, to a patient. The patient is a doctor’s responsibility, but in such a context, the blame will lie with the chemist, Gulati explained, calling for greater debate on the issue.

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