Over 3 per cent of 84,874 drug samples tested in 2020-21 were found substandard: Govt

More than three per cent of the 84,874 drug samples tested in 2020-21 were declared not of standard quality and 263 of them were found to be spurious and adulterated, Minister of State for Health Bharati Pravin Pawar told the Rajya Sabha on Tuesday.

The data was based on information received from state and Union territory drug controllers and the Central Drugs Standard Control Organisation (CDSCO), Pawar said in written reply to a question.

Whenever complaints regarding quality of medicines are received, the CDSCO in coordination with state licensing authority takes action according to provisions of the Drugs and Cosmetics Act and Rules. 

Of the total 84,874 drug samples tested in 2020-21, she said, 2,652 samples (3.12 per cent) were declared not of standard quality and 263 samples (0.31 per cent) were declared spurious and adulterated drugs.

On whether the government plans to develop an authentication ecosystem to curb the circulation of substandard medicines in the market, Pawar said various regulatory measures have been taken to ensure the quality of medicines.

These include notification for affixing bar code or quick response code in active pharmaceutical ingredients (APIs) and some drug formulations, increase in sanctioned regulatory posts of CDSCO and notification providing marketers of any drug to be responsible for its quality, she said.

Further, testing capacities of central drugs testing laboratories under the CDSCO have been strengthened, and the Drugs and Cosmetics Rules have been amended making it mandatory that the applicants shall submit evidence of stability, safety of excipients, etc. to the State Licensing Authority before grant of product manufacturing license.

Further the applicant shall submit the result of bio-equivalence study along with the application for grant of manufacturing license of oral dosage form of drugs falling under the categories II and IV of the Biopharmaceutical Classification System, she said in the written reply.

The central government has provided Rs 647.47 crore for strengthening the drug regulatory system including upgradation of existing state laboratories, setting up of new drug testing laboratories and upgradation of existing state drug control offices, Pawar said.