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Health ministry meets industry associations to discuss various problems faced by industry
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Swati Rana, Mumbai
November 19 , 2016
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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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TOPICS
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