Himachal Pradesh High Court Calls for Stringent Oversight of Drug Manufacturing Practices Amid Quality Failures
Shimla, November 5, 2024: In a major step towards addressing drug quality issues in Himachal Pradesh, the High Court expressed concern over repeated failures in drug quality testing and ordered a comprehensive examination of manufacturing standards across the state.
Acting Chief Justice Tarlok Singh Chauhan and Judge Satyen Vaidya, in their remarks, highlighted the need for stricter controls in the pharmaceutical manufacturing process, especially given Himachal Pradesh’s status as a major drug manufacturing hub in Asia, with over 600 pharmaceutical units.
This intervention arose during a Public Interest Litigation (PIL) hearing, where the court underscored lapses in regulatory compliance by manufacturers and urged the state to address deficiencies in testing and quality assurance.
Court Observations
The court noted that drug manufacturers are bound by Rule 71 of the Drugs and Cosmetics Rules, 1945, which mandates adequate staff, equipment, and independent testing units for drugs.
However, evidence showed that existing practices are falling short. In particular, the court observed:
Weak In-house Testing Protocols: Drug manufacturers are legally allowed to conduct tests on their raw materials and final products in their own laboratories.
The court raised concerns about the potential for compromised authenticity in these tests, citing the lack of sufficient regulatory oversight.
Push for NABL Accreditation:
Noting frequent sample failures, the court recommended that all drug testing labs, whether in-house or approved by state authorities, should be accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL). This measure, the court believes, will improve reliability in test results.
Enhanced Traceability and Consumer Access:
Following a recent amendment to Rule 96 by the Ministry of Health and Family Welfare, which mandates QR codes for Schedule H2 drugs, the court suggested extending this requirement to all drugs.
This would allow consumers to scan drug packaging to verify key details, such as manufacturing and expiry dates, with a simple mobile app.
The court further highlighted ambiguities in the identity verification of drug examiners, advocating for clear labeling that includes the examiner's registration number from the Pharmacy Council.
Additionally, computer-generated certificates should require digital signatures to strengthen accountability.
Expert Input and Pending Decisions
Senior Advocate Rajneesh Maniktala argued that regulatory provisions must require tests to be conducted both in-house and at external laboratories.
The court has deferred its decision on this matter, pending the state’s response.
Additionally, it directed the state to produce a copy of the Mashelkar Committee report on drug regulatory issues, expected to be reviewed at the next hearing on November 19.
The court has given the respondents time to file detailed affidavits addressing these recommendations.
This case underscores a push for heightened scrutiny of drug manufacturing standards in Himachal Pradesh, as regulators and manufacturers need to work to restore public trust in pharmaceutical products produced in the state.
