More than 3,000 drugs found substandard in 2022-23, 424 declared spurious or adulterated, says health ministry
Fake Medicines in India Data: As many as 3,053 drugs were found to be substandard while 424 medicines were declared as "spurious" or "adulterated" in FY23, according to official data submitted in the Lok Sabha on July 26. Read on to know the key takeaways from the report.
Fake Medicines in India Data: In the financial year 2022-23, as many as 3,053 drugs were found to be substandard while 424 medicines were declared as "spurious" or "adulterated", the Narendra Modi 3.0 government submitted in response to questions on substandard and spurious drugs in the Lok Sabha - the lower house of Parliament - on Friday, citing information received from authorities in various States and Union Territories. In a bid to ensure the quality of drugs and assess regulatory compliance at medicine-producing facilities, the Central Drugs Standard Control Organisation (CDSCO) - the national regulatory body under the health ministry - conducted risk-based inspections of more than 400 premises in the country along with State Drugs Controllers (SDCs), Minister of State for Health and Family Welfare Anupriya Patel submitted in the House of the People.
SUBSTANDARD & SPURIOUS DRUGS ISSUE | Action taken
More than 300 actions - such as issuance of show-cause notices, stop production orders, suspensions, licence cancellations - were taken by the State authorities as per the Drugs Rules 1945, as per the response submitted in Parliament.
Steps taken by CDSCO to ensure quality of medicines
The Drugs and Cosmetics Act, 1940, amended under Drugs & Cosmetics
(Amendment) Act 2008: The changes in rules provide for stringent penalties in cases where drugs are found to be spurious/adulterated, making certain offenses cognizable and non-bailable.
Special courts have been formed by states and UTs for trial of offences under the Drugs and Cosmetics Act.
No. of sanctioned posts in CDSCO significantly increased over 10 years
The number of sanctioned posts in the regulatory body has been increased in the past 10 years, according to the response.
Drugs and Cosmetics Rules amended
Applicant will have to submit the result of bioequivalence study along with application for grant of manufacturing licence of oral dosage form of some drugs
Drugs and Cosmetics Rules amended
Before grant of manufacturing licence, manufacturing establishment to be inspected jointly by drugs inspectors of central and state governments
Drugs and Cosmetics Rules amended
Applicants to mandatorily submit evidence of stability, safety of excipients etc. to state
licensing authorities before grant of manufacturing license
SUBSTANDARD & SPURIOUS DRUGS ISSUE | Action taken
The central government has amended the Drugs Rules 1945 to revise certain rules related to Good Manufacturing Practices and requirements of premises, plant, and equipment for pharmaceutical products.
How were firms identified?
They were identified based on risk criteria like the number of drugs declared as 'Not of Standard Quality', complaints, criticality of the products, etc.