The Union health ministry recently met the pharma industry associations, Indian Drug Manufacturers’ Association (IDMA) and Federation of Pharmaceuticals Entrepreneurs (FOPE) to discuss various issues that are affecting the growth of the sector. Issues related to FDC, extending the validity of CoPP certificate and support to SMEs had an in-depth discussion.
S V Veerramani, president of IDMA says, “The ministry wanted to know about the problems faced by the industry so they had called for the meeting. They had given a patiently listening to the issues shared in the meeting and has assured to look into the matter.”
The association has urged the secretary of health ministry that all the FDCs which are approved by Kokate Committee should be uploaded on the website and the government should allow the companies to market those FDCs. Earlier, the ministry had prohibited 344 FDC drugs for human use under section 26 A of Drugs and Cosmetics Act (D&C Act) 1940. The ban was based on the recommendations of Kokate Committee, which has affected several multinational and Indian companies.
The association wants the government to support the SMEs and bulk drug manufacturers by providing funds to encourage the manufacturing of APIs in India and reduce the dependency on China.
Another issue which the association wants the government to consider is to increase the validity of CoPP certificate from 2 years to 5 years and if not 5 years, then at least 3 years, as the current validation period is affecting the pharma export. The renewing of CoPP after every two years takes more time as the drug authorities have to do a re-inspection of the manufacturing facilities. But the re-inspection is not possible in time due to various constraints which further delays the renewing of the certificate. The industry is urging to increase the validity of certificate at least to 3 years because most of the countries are not considering the CoPP certificate with the remaining validity of 6 months.
IDMA has also submitted the list of around 4,000 ingredients, additives that are required for the health supplements. We have requested that it should be included in the Food and Safety Standard Act by FSSAI, said Veerramani.
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