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Pharmexcil sends suggestions to Commerce ministry to deal with Vietnam crisis
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Laxmi Yadav, Mumbai
September 21 , 2018
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In an effort to resolve challenges faced by Indian pharmaceutical exporters in Vietnam in the wake of latter's tightening of regulatory requirements to ensure quality of imported products, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has come out with a slew of suggestions for consideration of importing country including appointment of pre-shipment agency by Drug Administration of Vietnam (DAV).
The other suggestions include formation of joint working group on pharmaceuticals, appointment of nodal officers, MoU between DAV and Indian drug regulatory agency, CDSCO etc. The suggestions have been sent to Union ministry of commerce by Pharmexcil so that they can be included in the agenda of 4th Joint Sub Commission on Trade with Vietnam.
The DAV may adopt pre-shipment quality assurance by appointing their own inspection and testing agency in India. Some of the countries like Nigeria are successfully following this model. Commerce ministry/Pharmexcil can extend necessary assistance in identification of the agency, stated the Council.
In view of the government of India's proactive action of setting up international cell in National Drug Authority (CDSCO) New Delhi, DAV may initiate joint action with CDSCO by ensuring required compliance from defaulting firms. DAV may refer any suspected documents to international cell of CDSCO for cross verification and authentication.
A MoU may be signed between CDSCO and DA for regular interactions. Nodal officers may be appointed by DAV, CDSCO and Pharmexcil for exchange of regular and quick information on matters involving quality registrations and other concerns of the drug industry, added the Council.
The Pharmexcil also suggested that CDSCO should actively take up the issue with the State Licensing Authorities (SLAs) for a uniform format of Certificate of Pharmaceutical Product (CoPP) throughout the country in the wake of Vietnam's insistence on uniformity in CoPP.
A draft circular on registration of drugs and medicinal ingredients issued by the Ministry of Health, Vietnam on July 16, 2018 has mandated CoPP for product registrations and imported generic drugs, new chemical drugs and biologicals, pack insert etc making it impractical for Indian pharmaceutical companies to continue business in Vietnam.
The circular has also made implementation of QR code mandatory for exporters thus creating another stumbling block for Indian drug makers who are complying with barcode.
Another draft of circular amending and supplementing circular no. 11/2016/TT-BYT dated May 11, 2016 on prescribing the bidding for medicines at public medical establishments issued by the Vietnam health ministry on July 30, 2018 will keep most of the Indian pharma companies away from bidding groups of pharma finished products in hospitals in Vietnam except for Group 5 (only WHO GMP companies). India may lose more than US$ 200 million business and many Indian pharma companies will be forced to move out.
The draft stated that drugs are licensed for marketing in ICH standing member countries or founding member companies or Australia and that are manufacturing entirely on EU-GMP or equivalent manufacturing lines in an ICH standing member country or founding member country or Australia and the manufacturing line is certified by the pharmaceutical regulatory authority of that country would fall under Group 2A. Due to the stipulations of division, drugs fulfilled EU-GMP and manufactured in the country other than ICH’s members or Australia under Circular 11 will no longer be categorized in Group 2A. This may adversely affect the right to participate in the bid of potential drug suppliers.
The Pharmexcil has proposed that at Group 2 of Appendix 1, the condition regarding the country where the production line is set, particularly the standing members or founding members of ICH or Australia granted certificates by pharmaceutical agencies of these countries should be removed. Quality generics produced by manufacturing unit complying EU-GMP or equivalent, certified by reference pharmaceutical management agencies must be considered under Group 2.
It further said that the cooperation should be extended to the companies holding WHO GMP certification from India side. In practice, the drugs produced at production establishments that fulfills EU-GMP/US FDA/WHO GMP has the similar quality without needing to determine where the drugs are being produced, it concluded.
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