Govt eyes stricter drug norms to ensure patient safety

The Indian government is looking at stricter norms for drug companies to ensure patient safety, reports CNBC-TV18's Archana Shukla. This move comes at a time of rising drug marketing malpractices.

The Department of Pharmaceuticals has paced up work on the mandatory drug marketing code which will penalise drug firms' practices of giving gifts and incentives to doctors to prescribe their medicines which often results in patients being forced to buy expensive medicines.

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While there are already certain guidelines issued by various pharma lobbies like the Organisation of Pharmaceutical Producers of India (OPPI) and the Indian Drug Manufacturers Association (IDMA), ministry officials say the new code will have binding laws and is likely to be formulated as an act in due course.

BK Singh, director, pharma department, Government of India says, "It will look into how the drug is promoted. What interactions do companies have with doctors and to see that no sponsored seminars are being offered to the doctors."

This is not all there is to the government's norms. With a parliamentary report last year highlighting the fact that the central drug regulator was plagued by issues of inadequate infrastructure, shortage of drug inspectors and lack of accurate data, the Health Ministry is now adding 12 more drug advisory committees to evaluate new drug approvals, besides, ramping up its pool of drug inspectors to 2,500 by next year from just 120 now.

Shailendra Kumar, director, Health Ministry says, "All the state drug control departments, barring a few, do not have the capacity to even check medicines. We are going to spend Rs 1,200 crore just to improve the capacity of the state drug control departments."

In keeping with its healthcare affordability agenda, the government is looking to provide free diagnostic services at rural centers, but before doing that, the government is first focusing on defining a dedicated regulatory framework for medical devices used in the diagnostics industry. This proposal may be presented in the parliament in the ongoing session itself.

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