Dru regulation in India

Dru regulation in India

Subject: Government Schemes

Context: Gambia drug incident

• The Central authority is the overall supervisory body and direct States to ensure that the raw materials used are tested for purity.
• The state regulators are responsible for licensing the manufacture, sale and distribution of drugs in their respective states or union territories along with conducting inspections in the plants in line with central laws.
  • They also conduct checks for counterfeit or substandard drugs while also monitoring the quality of drugs in the state.
• 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 the Drug Controller General of India, DCGI.
    • DCGI is the head of the pharma regulatory framework in the country.
    • 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.
    • It is the appellate authority if there is any dispute with respect to the quality of the drug.
  • Role of CDSCO
    • Prescribes standards and measures for ensuring the safety, efficacy and quality of drugs including vaccines, cosmetics, diagnostics and devices as per the New Drugs and Clinical Trials Rules, 2019, under the Drugs and Cosmetics Act, 1940.
    • It is the nodal authority for the approval of new drugs and clinical trials in the country.
    • CDSCO regulates export of drugs in India, any manufacturer with the certification from CDSCO can export drugs outside India.
    • It coordinates activities of several state drug control organizations and provides expert advice to bring uniformity in the enforcement of the Drugs and Cosmetics Act.
    • It has power to ban a drug that is considered harmful or sub-therapeutic under Section 26A of the act.
    • It lays down the standards for drug control over the quality of imported drugs.
    • It is also responsible for granting licenses to government hospitals or medical institutions to import drugs for the use of their patients.
    • CDSCO is also a nodal authority for registering foreign manufacturers of drugs and medical devices that they want to ship to 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.

Drug approval process:

• A pharmaceutical company in India must have DGCI approval for selling a new prescription drug.
• Various stages of drug approval: 
  • application to conduct clinical trials,
  • conducting clinical trials–first on animals (if results are positive) then the findings are sent to the DCGI office with a request for conducting human trials of the drug.
  • application for authorising the marketing of the drug and
  • post-marketing studies