India to enforce WHO-GMP standards for all pharma products

Drugs 0507New Delhi (ISJ Exclusive) – India plans to enforce the quality standards for drugs and pharma products to become WHO-GMP compliant. The national drug regulator is working on a framework to gradually bring all pharmaceutical companies at par with the global standards in medicines.


World Health Organisation has drawn up a good manufacturing practice (GMP), to ensure healthcare products are ‘consistently produced and controlled’ according to quality standards.


“We want the entire pharma manufacturers to become WHO-GMP compliant. We are going to enhance our standards of the GMP. We have become an international supplier of medicines and want to keep pace with global expectations,” Dr. G.N. Singh, Drugs Controller General of India told Indian Science Journal on the sidelines of an event in Gurgaon, in the outskirts of the national capital on Wednesday (Aug 05).


WHO certification of quality is mandatory for pharmaceutical companies moving in international commerce. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which are broadly categorized in two groups – cross contamination or mix-ups and false labelling.


According to the Department of Pharmaceuticals, there are about 10,000 drug manufacturing units in India, out of which only 14-15% are WHO-GMP compliant. Officials of the department feels, if more companies adhere to the quality standards under WHO-GMP, India’s share in global pharma trade could go up by five times.


India is world’s third largest manufacturer of pharmaceutical products in terms of volume, while 14th in terms of value. The value of export in 2014-15 was 94,275 crore or US $ 15.2 billion and estimated to be 1,00,000 crores in 2014-15.


The loss to Indian companies during the fiscal 2014-15 due to ban by various countries is estimated to be between US $ 1-1.2 billion, according to industry sources.


- N.B. Nair


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