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Stricter safety norm may hold up copycat drugs
Panel Calls for Clear Timeframe for Allowing Generics
LONG before Pfizer decided to introduce its famed Viagra in India, nearly a dozen me-too pills had flooded the market here. Later, reports surfaced that the blue pill that helped millions to rise to the occasion, may have had a role in a small number of them losing eyesight. Of course, a drug is approved only when its benefits far outweigh the risks involved. But this practice of Indian pharmaceutical companies flooding the local market with copycat versions of MNC drugs immediately after they hit the international market may be restricted soon.
The Satwant Reddy panel on drug data exclusivity has recommended that there should be clarity on how long India should wait and watch a global brand before Indian companies seeking to sell that product here can be given any waiver in the approval requirements. The existing law merely says ’several years.’ Any relaxation on generation of clinical data should be granted only after the expiry of a more clearly specified time, the report recommends.
Unlike in the US, India does not have strong laws for seeking compensation from a drug maker for injuries due to a drug’s side effects. The issue is crucial as Indian companies do not prove their copy’s safety and efficacy directly. Instead, they show limited research data to prove that their copy is similar to the drug that is approved by a sophisticated foreign drug regulator and that their copy is available in the blood stream at similar levels.
Accepting the judgement of a more equipped regulator is fine. But sometimes, drugs meant to treat minor ailments may report serious life threatening side effects later on, leading to its recall in other countries. Some rare side effects surface only when a drug is used by a large section of the population for many years. Regulators find it difficult to wait that long before giving the benefits of that drug to a large section of the needy population. In the absence of clarity on how long India should wait before approving a copy, the instinct and the judgement of the drug controller general counts.
University of Sydney dean and a panellist of 12 international clinical studies, professor Andrew JS Coats told ET during a recent visit that drug control departments the world over should make approval criteria more stringent in the case of life style drugs, and relax or maintain status quo on drugs for life threatening diseases. More clinical studies could be demanded for drugs meant for symptomatic relief as a better informed approval decision would justify the time delay. However, for drugs treating life threatening diseases, the emphasis could be to make the therapeutic benefit available to patients at the earliest as per the present norms.
“It is a scientific dilemma between protecting consumers from side effects unknown at the time of approval while at the same time not closing the doors on a new drug’s therapeutic benefits. This becomes difficult as there is no 100% validated method to predict the safety of a drug. As more data emerge from mass consumption, unknown chemical aspects of a drug also emerge,” former Drugs Controller General of India Ashwini Kumar told ET. The government is likely to take the panel’s suggestion seriously.
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