The validities of WHO GMP/CoPP expiring between March to August 2020 will be extended by six months from the date of expiry of the certificate as per WHO GMP certification guidelines
The Central Drugs Standard Control Organisation (CDSCO) has issued a letter to all the States and Union Territories Drug Controllers informing about a six-month extension of validity of WHO – GMP/Certificate of Pharmaceutical Product (CoPP).
The COPP is issued under the WHO-GMP Certification Scheme for the purpose of international commerce i.e.; registration of products in foreign countries. The validity of CoPP was extended from two to three years vide Office Memorandum No; 7-5/2018/Misc/048 dated May 8, 2018.
Now, an extension will be given to those whose validities are expiring between March and August 2020. This comes after earlier this year, pharma industry stakeholders had made representations to the CDSCO office requesting an extension in validity of the COPP due to COVID-19 crisis in the country.
The letter issued by the CDSCO office mentions that the matter has been examined in light of the Coronavirus outbreak in the country and in order to maintain continuity of essential activities by the pharma industry, it has been decided that the validity of WHO GMP/CoPP expiring from March to August 2020 may be extended by six months from the date of expiry of the certificate as per WHO GMP certification guidelines.
Commenting on this move, Narendra Ahooja, State Drug Controller, Haryana said, “This is a right decision taken by the competent authority of CDSCO to allow the state licensing authority/ state drug controller to revalidate the WHO GMP site certification/CoPP for a further six months. Due to the extraordinary situation that arisen due to COVID-19 in the country, it is difficult to conduct inspections. Why should the industry suffer and exports get adversely impacted when it brings foreign money for the exchequer. Hence, it is a positive move.”
Manmohan Taneja, Assistant State Drugs Controller, Haryana, “It is a welcome step and will certainly be of great help to the India pharma industry. The WHO site certificate is revalidated after a joint inspection of the manufacturing site by State FDA and CDSCO officers and only if the site complies with WHO-TRS. In the present situation, when the country is under lockdown, such inspections are difficult to carry out, hence exports would have come to standstill for the want of WHO certificates. This decision is a breather for the industry.”
Mahesh Doshi, President, Indian Drugs Manufacturers Association (IDMA) said,” Nearly 10-12 days back we had made the representation to the CDSCO office and expressed our concerns, particularly in regards to the CoPP since it is a requirement for exports. With this extension, there will be continuity in exports and industry will see the smooth functioning of their export activities. Overall, the industry is very happy with this move and appreciates the decision which is taken in time and will help the nation’s economy.”
Dr Dinesh Dua, Chairman, Pharmaceuticals Export Promotion Council of India (Pharmexcil), said, “It is a very good step taken by the DCGI. Because, the renewal process requires lots of documentation as well as physical inspection, and due to the lockdown period, we have already lost one and a half months. And there is gradual destruction in our export performance, as it got eroded by 50 per cent in the month of March and April. The industry is expecting some relief announcement after the lockdown ends on May 3, certainly, this will give a relief to the industry.”
B R Sikri, Chairman, Federation of Pharma Entrepreneurs (FOPE) and VP, Bulk Drug Manufacturers Association (BDMA) said, “This extension of six months by the CDSCO office will ensure continuity of the essential activities by our industry and our exports will not get affected. Industry feels honoured to see such positive actions being taken by the government. It is working as a partner with the industry to ensure the availability of medicines, not only in India but also in the international markets. This will further strengthen Brand India’s image in the global pharma market.”
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That’s a good decision under present circumstances. Now it is the ones of manufacturers to ensure adherence to CGMP. This must not be taken for advantage and keep the compliance aside. The blanket extension is basically not to affect the export. Additionally the COPPs also need to be revalidated, so what modalities will be adopted.