Drug Recall Law in India

Why in news?

• Recent failures of Indian manufactured drugs overseas have brought attention to the issue of absence of a drug recall law in the pharmaceutical industry in India.

What is Drug Recall?

• Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety.
• The defective products related to quality include Not of Standard Quality, Adulterated or Spurious drugs.

Status of Drug Recall Law in India:

• India has been considering the creation of a mandatory recall law for substandard drugs since 1976, but still no law exists that mandates such medicine be removed from the market.
• In 2012, the Central Drugs Standard Control Organisation (CDSCO) proposed a set of draft recall guidelines but the national regulator lacks the power to convert guidelines into a binding law.

Present Laws Regulating the Drugs in India:

• Central Drugs Standard Control Organisation:
  • It is under Directorate General of Health Services, Ministry of Health & Family Welfare
  • Under the Drugs and Cosmetics Act, CDSCO is responsible for:
    • Approval of New Drugs
    • Conduct of Clinical Trials
    • Laying down the standards for Drugs
    • Control over the quality of imported drugs in the country and
    • Coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
  • CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
• The Drugs & Cosmetics Act, 1940:
  • It regulates the import, manufacture, distribution and sale of drugs in India.
• The Pharmacy Act,1948:
  • It is meant to regulate the profession of Pharmacy in India.
• The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954:
  • It provides to control the advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities.
• The Narcotic Drugs and Psychotropic Substances Act, 1985:
  • It is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances.
• National Pharmaceutical Pricing Authority:
  • It is an organization of the Government of India which was established, inter alia, to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995.
  • The organization is also entrusted with the task of recovering amounts overcharged by manufacturers for the controlled drugs from the consumers. It also monitors the prices of decontrolled drugs in order to keep them at reasonable levels.

PRACTICE QUESTION

Consider the following statements:

1. Drugs & Cosmetics Act, 1940 regulates the manufacture and sale of drugs in India.

2. Central Drugs Standard Control Organisation is responsible for approval of new drugs

Which of the statements given above is/are correct?

(a) 1 only

(b) 2 only

(c) Both 1 and 2

(d) Neither 1 nor 2

Answer