Industry is gathering scientific data to approach the regulator, DCGI, for a review of the suspension order
Major drug makers, including Sun Pharmaceutical Industries and Lupin, are strongly opposing the government’s recent move to ban the popular anti-diabetic drug pioglitazone, in India.
The industry claims the medicine was banned suddenly without following the proper consultation process with the Drug Technical Advisory Board (DTAB) or the companies.
The industry is gathering scientific data to approach the regulator, Drugs Controller General of India (DCGI), for a review of the suspension order. If that doesn’t work, legal options could be tapped to challenge the suspension.
“We are demanding a review. A ban has to be based on science and scientific data. It has to follow a proper process and be evaluated by the DTAB and with the knowledge and consultation of the industry,” said Indian Pharmaceutical Alliance secretary general D G Shah. He added if the government did not seek the industry’s views and review the suspension of pioglitazone, the industry body might evaluate legal options to challenge the process of imposing the ban.
Lupin, which sells pioglitazone-based combinations, said it was surprised at with the government’s decision as the drug was in use in many major markets. “This drug is in use in most advanced markets of the world, be it the US, Japan or the UK. I believe the DCGI has invited comments and responses from the industry and it should come up for review, which would be a very welcome step,” Lupin group president, India and CIS (Commonwealth of Independent States) Shakti Chakraborty told Business Standard. Pioglitazone is currently available in India under various brands such as Diavista by Dr Reddy’s Laboratories, Sun Pharma’s Pioglit and Pioglar by Ranbaxy Laboratories.
The drug commands a market of Rs 700 crore. According to a DCGI official, the government is likely to review its order. “The case is under consideration. We can review the order if the industry submits enough scientific evidence in favour of the drug,” said the official, who did not want to be named.
In June, the government notified suspension of manufacture and sale of pioglitazone, along with two other medicines, analgin and deanxit, in the country without specifiying reason.
Sources say it was triggered by the health ministry’s commitment to a parliamentary committee that it would immediately suspend medicines not allowed for sale in major international markets.
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