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India tightens regulation on generics manufacturers

Home/Policies & Legislation | Posted 08/02/2019 0 Post your comment

The pharmaceutical industry in India ranks third in the world in terms of volume and is the largest provider of generic medicines globally. However, concerns over the quality of generics manufacturing have affected utilization in India. This is demonstrated by poor sales in Jan Aushadhi outlets, which are government-run retail outlets providing generic medicines at an affordable price.

‘The confidence in generic medicines isn’t up to the mark among people, which reflects in the sales at the Jan Aushadhi stores. Of the 3,000 plus stores that we have, barely 10 to 15 have a turnover of more than Rs 50,000,” said Dr S Eswara Reddy, Drug Controller General of India.

To address these concerns and boost public confidence in generic medicines, stringent quality control measures will be put in place. These will oblige manufacturers of generic medicines seeking licences to demonstrate quality and safety equivalence to an approved reference product.

Dr R Chandrashekhar, Deputy Drug Controller, Central Drugs Standard Control Organization states: ‘It is part of the data collected under the BA/BE (bioavailability and bioequivalence) study, wherein the reference product or the first brand will be given by the drug controller that is duly tested’.

‘The onus will lie on the generics manufacturer to prove that the quality of their drug is similar to the branded one’, he said during the 70th Indian Pharmaceutical Congress.

At the moment, many states do not have their own drug testing laboratories, and only a small number are accredited by the National Accreditation Board for Testing and Calibration Laboratories. Dr Reddy’s reports that resources have been allocated, the workforce has been trained and regulatory standards are in the process of being upgraded up to an international standard, so that the Drugs and Cosmetics Act can be uniformly implemented across the country. He estimates that nearly 70% of generic manufacturers in India are reasonably compliant, and states that the focus will be on manufacturers who are not compliant.

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