The CDSCO has unveiled an integrated strategy for 2024 for addressing the spurious and substandard medicine problem in India, which it claims has not seen a remission. According to this strategy, stricter inspections and increased monitoring and a collaborative effort with states and UTs shall be made regarding the quality and safety of drugs.

Key Highlights

1. Focus Areas for 2024:

2. Risk-Based Inspections (RBI): Greater emphasis on focussed inspections to identify high-risk manufacturers and distributors.

3. Monitoring and Sampling: More sophisticated and extensive sampling of drugs to enforce compliance.

4. Sensitization and Enforcement: Nation-wide campaigns and action against violators.

  2.  Coordination with States and UTs:

• States and UTs have been directed to actively share data on spurious and sub-standard drugs with the Center.

• Efforts are being taken in collaboration with state governments to improve surveillance and ensure the quality of drugs.

  3.  Schedule M Compliance Compulsory:

• Effective January 1, 2024, MSME drug manufacturers with a turnover of less than ₹250 crore have to be Schedule M Good Manufacturing Practices (GMP) compliant.

• Strict regulatory action would be taken against non-compliant firms.

 4. Implementation of Bar Code for Top 300 Brands:
 Pharma companies must now print bar codes or QR codes on formulations scheduled under Schedule H2, which shall further allow better traceability
and the detection of spurious drugs. 5. Latest Notable Gains:
 The Centre recently, in an impressive combined operation with the West Bengal government, busted a major spurious drug trade in Kolkata.6. Zero Tolerance to Spurious and Substandard Drugs:
 The Centre again reiterated its zero-tolerance policy on spurious and substandard drugs stating that these were responsible for treatment failures, adverse reactions, increased morbidity, and mortality.

Statements by the officials
An anonymous official stated:
 “The government is very serious about the quality of drugs. We are aggressively pursuing Schedule M GMP compliance and keeping a close check on  spurious drugs. Non-compliance will not be tolerated.”

Challenges Addressed by the Initiative:
Spurious and substandard drugs contribute to adverse health outcomes, including treatment failures and drug resistance.
Collaborative measures aim to streamline enforcement and ensure that essential medications meet quality standards.The aggressive plan of CDSCO in the fight against spurious drugs is a commitment on the part of India toward drug safety and maintaining public health. This move, by including state governments and ensuring GMP compliance for MSME manufacturers, will be the big difference-maker in 2024.