Introduction

Recently, the need for the Drug Recall Law in India and the issue of circulating substandard drugs has gained attention as a pharmaceutical company negligently shipped a mislabeled batch of Drugs to the market.

• Since, 1976, India has been reflecting on the formulation of a mandatory recall law for substandard drugs. The act of drug recall is prevalent in the US as such recalls take place regularly there, but not seen in India.

What is a Drug Recall?

• The process of removing or correcting a marketed drug product that violates the laws and regulations governing the safety, efficacy, or quality of a drug is considered a Drug Recall.
• It occurs when a medication that is available either by prescription or over the counter is removed from the market because of its harmful or side effects.
• They are issued when a product is found to be defective, contaminated, mislabeled, or poses a risk to the health and safety of patients.
• They are done with the objective of providing protection to the public by removing the affected product from the market and it also provides a refund to those who have already purchased the product.

What is the Background of Drug Recall in India?

• In 1976, the Drugs Consultative Committee was comprised of drug controllers from all states with senior bureaucrats from Ministry of Health and national drug regulator, and the Central Drugs Standard Control Organization (CDSCO).
  • CDSCO participated in the discussion related to drug recall.
• The discussion was based on how drugs ordered to be recalled by a drug controller of one state were found to be on sale in another state.
• The matter was repeatedly invoked in regulatory meetings in 1989, 1996, 2004, 2007, 2016, 2018 and 2019 and none of them resulted in amendments to the Drugs and Cosmetics Act, 1940 to create a mandatory recall mechanism.

What is the Need for the Drug Recall Law in India?

• A Drug Recall Law is needed in India so that an entire batch of substandard drugs can be withdrawn from the market effortlessly as soon as it is identified as Not of Standard Quality (NSQ).
• The state drug regulators can direct the withdrawal of certain batch from their respective states only as there is no such law in India to withdraw the entire batch of substandard drugs from the market.
• A central drug regulator is needed for the purpose of executing and coordinating national recalls.

What are the Reasons for No Recall Law?

• The Drug regulation section of the Union Health Ministry is not involved in resolving the drug regulatory problems due to dearth of apathy and expertise.
• One of the major reasons is the growth of interest in pharmaceutical regime than public health.
• Diverse regulatory structure in India is also a reason as each state has its own regulator.
• Bureaucratic intention to avoid accountability.

What is the Aftermath of Lack of Law?

• People, including children, are almost dying or undergoing severe side effects because the substandard drugs are not removed from the market.
• Dozens of drugs escape the random testing in government laboratories every month.

What are the Legal Provisions Related to Drugs Regulations in India?

Drugs and Cosmetics Act, 1940

• The Drugs and Cosmetics Act, 1940 was enacted on 10^th April 1940.
• It is an act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
• As per section 3 (b) of this act, a drug includes—

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes

(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette

(iii) all substances intended for use as components of a drug including empty gelatin capsules; and

(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

Way Forward

• To create effective recall mechanism the responsibility of recalling drugs must be centralized.
• There must be one authority wielding the legal power to hold companies accountable for failures to recall drugs across the nation.
• An amendment is required in the Drugs and Cosmetics Act, of 1940 to bring the recall law into effect and make the system centralized.