CDSCO getting more stricter towards the quality and safety of Generic Medicines

Medicare News

Central Drugs Standard Control Organization(CDSCO) is making efforts to improve the drug quality of generic medicines to boost public confidence in generic drugs. As a part of this movement, India’s drug controller is putting stringent quality control measures. All the generic drug manufacturers will have to assure the quality of the medicines and safety equivalence with a reference product that has already been tested by the regulator.

Dr. R Chandrashekhar, deputy drug controller, Central Drugs Standard Control Organization (CDSCO) said that this quality measures will be based on the data collected under the BA/BE (bioavailability and bioequivalence) study. Drug controller will give the reference product or the first brand that is duly tested and manufacturers need to prove their manufactured generic drug quality.

Dr. Chandrashekhar also shared that many manufacturers promoted wrongly that their product is of similar quality as the branded one, during the 70th Indian Pharmaceutical Congress held in the Amity University campus.

Because of quality and trust concerns, generic medicines have not gained popularity yet. Though the Indian government has been widely promoting generic medicines confidence among the consumers is not yet attained. Government analyzed the sales report of Jan-Aushadhi stores and which clearly defined the lack of confidence in generic medicines isn’t up to the mark among people.

Dr. S Eswara Reddy, drug controller general of India said that out of 3,000 plus stores, only 10-15 Jan-Aushadhi stores have a turnover of more than Rs 50,000.

FYI, Indian government running Jan-Aushadhi stores to provide low-cost generic medicines to Indian people. Dr. Reddy also said that there is still a need to gain enough confidence among masses towards the quality and safety of generic medicines as people usually prefer branded medicines first. Government trying hard to change that perception that branded drug is better than the generic one.

It also comes into the notice that infrastructure inadequacies and staffing shortages also hurt the central drugs control department. The Indian government allocated Rs 1,750 crore of funds in 2016, for strengthening central and state drug control departments, but no change noticed yet.

Dr. Reddy shared that many of the states still not having their own drug testing labs. Only 3-4 state drug controller labs are NABL(National Accreditation Board for Testing and Calibration Laboratories) accredited. He also said that the allocated funds will be utilized and we are working to upgrade regulatory standards up to the international level. We are also planning to give best training to the staff so that the Drugs and Cosmetics Act is uniformly implemented.

Dr. Reddy said that the drug department is very strict now and implementing rules to make generic drugs compliance of standards. About 70% of the manufacturing companies are reasonably compliant, but CDSCO focusing on manufacturers who aren’t compliant.


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