The CDSCO and the Ministry of Health and Family Welfare have taken several measures to ensure that the drugs produced in the country meet the required safety and efficacy standards
The number of batches of drugs recalled after failing quality tests rose from 950 in 2019-20 to 1,394 (provisional) in 2023-24, Minister of State for Health Anupriya Patel told the Rajya Sabha on Tuesday (December 17, 2024).
In 2022-23, 1,171 batches were recalled as per information received from drug controllers of various states and UTs, Patel said in a written reply.
The data regarding drugs recalled after failing quality tests is not maintained centrally by the Central Drugs Standard Control Organization (CDSCO).
During the year 2023-24 (April to March), 2,988 drug samples were declared not of standard quality while 282 drug samples were found to be spurious or adulterated, she said.
Based on the findings, 604 prosecutions were launched for the manufacturing, sale and distribution of spurious/adulterated drugs. A total of 1,06,150 drug samples were tested during the period, she said in the written reply.
The CDSCO and the Ministry of Health and Family Welfare have taken several measures to ensure that the drugs produced in the country meet the required safety and efficacy standards.
In order to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO along with State Drugs Controllers (SDCs) initiated risk-based inspections of drug manufacturing firms in December 2022.
The risk-based inspections of more than 500 premises have been conducted so far. Drug manufacturing firms have been identified based on risk criteria like the number of drugs declared as Not of Standard Quality, complaints, criticality of the products etc.
Based on findings of inspections, more than 400 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules 1945.
The central government has amended the Drugs Rules 1945 vide dated 28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products.
Revised Schedule M has become effective for drug manufacturers with a turnover of more than 250 crores from 29.06.2024.