Justice Lent in Commission and Drug safety regulation

Subject :Governance

Context:

66 children died in Gambia, possibly from the presence of DEG or diethylene glycol in four cough syrups that were sent from India calling for an overhaul of the drug regulatory.
It’s been 36 years since the Justice Lentin Commission probed the death of 14 people at Mumbai’s JJ Hospital. The deaths were linked to DEG or diethylene glycol, a toxic contaminant that should not have been in the medicine.

Details:

Lentin Commission (1986) report makes a case for a strong regulatory authority and accountability in drug testing and control along:
- Investments in training more personnel and strengthening laboratories across the country.
- Implement Good Manufacturing Practices (cGMP) norms,
- Central regulators are given greater autonomy to function, citing examples of Brazil and Ghana.

Concept:

Health is a state subject
The Central authority is the overall supervisory body and direct States to ensure that the raw materials used are tested for purity.
The State gives manufacturing licences and inspects plants, etc., in line with central laws.
The Drug and Cosmetics Act, 1940 establishes regulatory control over the import, manufacture, distribution, and sale of drugs and cosmetics in India.
- It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP).
- This also established the Central Drugs Standard Control Organization (CDSCO) headed by Drug Controller General of India, DCGI
  - DCGI is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India. It also sets standards for manufacturing, sales, import, and distribution of drugs in India

- Role of CDSCO
  - Prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country.
  - Regulates the market authorization of new drugs and clinical trials standards.
  - Supervises drug imports and approves licences to manufacture the above-mentioned products.
  - CDSCO regulates export of drugs in India, any manufacturer with the certification from CDSCO can export drugs outside India.
The State Health department has to regulate the manufacturing, sales, and distribution of drugs.
Drug Inspectors control the implementation at ground level.
The Drugs and Cosmetics Act also has provisions of recalling of substandard drugs from the market, to compensate the families of victims of adulteration.