New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has recently released an updated list of WHO GMP Certified Manufacturing Units for Certificate of Pharmaceutical Products (COPP) across the various States of India.
Every country has its own system and requirements for registering a pharmaceutical product to ensure that the product being registered meet their standards for efficacy, safety and quality.
The Indian pharma regulator has been issuing the Certificate of Pharmaceutical Products (COPP) which is valid for a period of only two years. The COPP is the legal document that declares a certain manufacturing company is legally allowed to sell their pharmaceutical product in the country they are producing. When registering a pharmaceutical product overseas, the government body in charge of approving the application will usually require a COPP to ensure that the product is being sold as a commercial finished product in the country that is producing it
The COPP is on par with the WHO-GMP certificates.
WHO-GMP certifications of a Group’s manufacturing facilities are a testimony to its compliance with the World Health Organization’s (WHO) international norms. It is a system (and part of the quality assurance programme) to ensure that the pharmaceutical products are consistently produced and controlled according to the quality standard. It is designed to minimize the risk involved in any pharmaceutical production that cannot be eliminated through testing the finished product.
Recently, CDSCO has released a list of manufacturing units that fall under WHO GMP certification. The notification reads a total of 2006 WHO GMP Certified Manufacturers in different states of India. A large number of manufacturers are in the state of Gujarat with 684 manufacturers, followed by 229 manufacturers in Maharashtra.
Few of the major pharma companies mentioned in the list include Sun Pharma, Aurobindo Pharma, Dr Reddy’s Labs, Indoco Remedies, Cadila healthcare, Unichem Labs, Cipla, Glenmark, Merck and others.
In India, the GMP was given statutory status much later in 1988 and were incorporated as Schedule M under Drugs and Cosmetics rules 1945. This was again revised in 2001 but implemented only in 2005 after stiff resistance from many small-scale manufacturers.