Drug lobby expects DCGI to ask questions

Drug lobby expects DCGI to ask questions
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First Published: Sun, Sep 07 2008. 10 32 PM IST
Updated: Mon, Sep 08 2008. 09 45 AM IST
Hyderabad/Mumbai: At least six of the 20 drugs being investigated by the US drug regulator food and drug administration, or FDA, for potential adverse effects are being sold in India by local and multinational drug makers.
The drugs—heparin, ivermectin, warfarin, nitroglycerine, octreotide acetate and quetiapine—are sold in India by firms including Sun Pharmaceuticals Ltd, Ranbaxy Laboratories Ltd, Lupin Ltd, GlaxoSmithKline Pharmaceuticals Ltd, Cipla Ltd and Torrent Pharmaceuticals Ltd.
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Two other products— fluorouracil cream and ketoconazole cream—were named by the FDA investigation for confusion arising among consumers over similar sounding brand names (Carac and Kuric, respectively) in the US.
They are sold in India by the likes of Sun Pharma and a local unit of Johnson and Johnson, but the names they sell under could not immediately be ascertained.
An industry representative predicted that the country’s drug quality regulator, the drugs controller general of India, or DCGI, would ask these firms for local data on any adverse reactions the drugs cause.
“In such instances, when FDA puts drugs on a watch list, what we have seen previously is that DCGI would ask the manufacturers of those drugs who market it in India for data regarding adverse reactions, which would then be evaluated to take a decision on the safety of the drug,” said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, an industry grouping.
DCGI Surender Singh could not be reached for comment on Sunday. Spokespersons for Ranbaxy, Sun and Torrent declined to comment.
An executive with an Indian drug maker, who did not want himself or his company to be identified, said FDA was merely flagging a safety concern that would require further investigation.
All Indian medicine makers will follow the law, added the executive, referring to any directive that DCGI may issue in this connection.
Prafull D. Sheth, vice-president of the think tank of pharmacists, the International Pharmaceutical Federation, said there was a need for “research into any kind of adverse drug reaction reported”.
Only by generating and analysing data from local markets can drugs with unacceptable levels of adverse reactions be kept away from consumers, he added.
India has not reported a single instance of medicinal side effects from drugs for the last three years to an international drug monitoring database, Uppsala Monitoring Centre, set up by the World Health Organization, Mint reported on 28 July. That indicated a near collapse of post-marketing drug scrutiny systems in the country.
DCGI Singh had then acknowledged that pharmacovigilance, the practice of monitoring drugs for adverse reactions after they had been approved and are sold to consumers, has been a problem. India’s laws require drug makers to conduct post-marketing surveillance studies of the medicines they manufacture or import, provisions that are overlooked by some companies, industry experts say. ”Not all companies do it,” Singh had said.
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First Published: Sun, Sep 07 2008. 10 32 PM IST
More Topics: US FDA | Side effects | Heparin | Warfarin | Ivermectin |