To boost public confidence in generic medicines, India’s drug controller is putting stringent quality control measures in place. As part of the move, generic drug manufacturers will have to prove quality and safety equivalence with a reference product that has already been tested by the regulator.
“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,” said Dr R Chandrashekhar, deputy drug controller, Central Drugs Standard Control Organization (CDSCO).
“The onus will lie on the generic manufacturer to prove that the quality of their drug is similar to the branded one,” he said during the 70th Indian Pharmaceutical Congress held in the Amity University campus on December 21.
Even though the government has been widely promoting generic medicines, these have not gained popularity because of quality concerns. “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 10-15 have a turnover of more than ₹50,000,” said Dr S Eswara Reddy, drug controller general of India. Jan-Aushadhi stores are government-run outlets that sell low-cost generic medicines.
“There needs to be enough confidence among masses as they still tend to ask for a branded drug first. As the country’s drug regulator, I feel the need to change that perception and build confidence among people,” said Dr Reddy.
{{/usCountry}}“There needs to be enough confidence among masses as they still tend to ask for a branded drug first. As the country’s drug regulator, I feel the need to change that perception and build confidence among people,” said Dr Reddy.
{{/usCountry}}The central drugs control department has been hurt by infrastructure inadequacies and staffing shortages in the past. In 2016, the government allocated ₹1,750 crore for strengthening central and state drug control departments.
“Many states don’t have their own drug testing labs and hardly three or four state drug controller labs are NABL accredited. The funds have been allocated and now we are in the process of upgrading regulatory standards up to the international level by training staff so that the Drugs and Cosmetics Act is uniformly implemented across the country,” said Dr Reddy. NABL is short for National Accreditation Board for Testing and Calibration Laboratories.
“The department will be very strict with compliance of standards. Nearly 70% of the companies are reasonably compliant, but our focus will be on manufacturers who aren’t compliant,” he said.