Banning of odd-344 fixed dose combination (FDCs) drugs may show India in poor light, the commerce ministry has told the Drug Controller General of India (DCGI).
FDCs combine two or more combinations in a single drug.
DCGI GN Singh was the top authority to impose ban on 344 FDCs in March this year. Commerce ministry, whose mandate is to earn investments by posing the country’s merit in ease of doing business, has now rapped DCGI to answer the concerns of top drug makers, including Gilead, Abbott and Pfizer, regarding the ban.
“I have met a delegation, including representatives from Gilead Life Sciences, Bill Gates Foundation, Clinton Foundation and World Health Organisation to answer their concerns,” Singh told HT.
Two top officials at the ministry of commerce and industry confirmed the raised concerns and said that “pharmaceuticals, both in foreign direct investment (FDI) and exports, is among the top yielding sector. Thus, the concerns raised by multinationals have to be addressed at the earliest.”
“Pharma giants have informed us about the (registration) delays, and various stumbling blocks in the industry. The concerns have increased manifold after the ban notification on 344 formulations. It concludes that ease of doing business is yet to be seen in the drug making sector. We have been holding discussions with the DCGI to find a solution,” said a top bureaucrat at the commerce ministry.
Though, DCGI Singh strongly stands against the sale of codeine-based,or irrational formulations, in India, he is now working closely with the commerce ministry officials on easing the drug registration and approval processes to compensate the harm caused by the drug ban.
“We plan to bring faster drug clearance process. With this, the clearance time will come down to 15 days from the current six to nine months. Also, the entire registration process is set to go online in the next six months,” he said. “We have been asked to work on increasing exports, create business-friendly environment along with hurdle-less issuance of no-objection certificates for drug manufacture and export... There are several other discussions on registration fees.”
Another commerce ministry official said that “the ministry is working with the DCGI to see how best he can ease down the lengthy drug registration and approval processes, keeping in mind the necessary requirements to control quality.”
Mails sent to pharma giants, including Abbott and Pfizer did not fetch any response. Moreover, the ban over FDCs is still sub-judice.
Over 150 petitions by pharma majors such as Pfizer, Glenmark, Procter and Gamble (P&G) and Cipla, have challenged the government’s March 10 decision, of banning the 344 FDCs.