DCGI to mandate separate rack for generics in pharmacies

CDSCO website will release a notification about the new provision for sale of medicines in India

The Central Drug Standard Control Organization (CDSCO) will soon come up with a provision mandating all pharmacies in India to have a separate rack in their premises for generic medicines. The initiative has been taken by Drugs Controller General of India (DCGI) to promote and increase accessibility of generic medicines in India.

Dr S Eswara Reddy, DCGI, speaking at IDMA-APA Pharmaceutical Analysts’ Convention (PAC) 2018, informed that this move was discussed at a Drug Testing Advisory Board (DTAB) meeting held on May 16, 2018. Dr Reddy said, “Under this provision all the pharmacy shops in India will need to have a separate shelves/space in their premises which is only for the storage of generic medicines. This is to ensure that whenever any patients visit any pharmacy, generic medicines are available. This will meet our objective of improving accessibility and affordability of medicines in our country.”

He further said, “In India, the market share of branded generic drugs is 85 per cent. The standard to maintain quality of drugs, whether it is generic drugs, branded drugs or branded generic drugs; whatever it is called the quality remains same for all. But, to ensure the quality of generic medicines, we have mandated Bioavailability and Bioequivalence (BA/BE) studies, especially for class B and class D drugs, classified under pharma drug classification, which are low soluble molecules and requires BA/BE data. As a regulator, we can only make rules and regulations but to ensure the quality of medicines we all need to have a strong commitment towards it.”

Speaking on the initiatives taken by the government to promote generic drugs, he said, “The government of India has taken various measures to strengthen and promote generics in India. We are issuing licenses to manufacture any drug with the generic name only for the medicines that are manufactured and sold in India. Permission has been granted only for generics. In 2016, the Medical Council of India has issued a circular stating that all physicians, clinicians to prescribe only generic medicines. The government of India has also introduced the concept of Jan Aushadhi.”