The lack of a drug recall law in India

• There is a rise of substandard drugs in India due to lack of regulatory standards and no law to recall drugs.

Drug regulation in India

• The Indian pharmaceutical industry ranks third globally in volume, estimated to be worth $42 billion.
• For a pharmaceutical company to offer a brand-new prescription medicine in India, DCGI (Drug Controller General of India) clearance is required..
• The drug controller general of India (DCGI) is the head of the Central Drugs Standard Control Organisation (CDSCO) in India. DCGI is the head of the pharma regulatory framework in the country.
• The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
• Under the Drug and Cosmetics Act(DCA), the regulation of the manufacture, sale, and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for the approval of New Drugs.

Challenges in regulation

• Fragmented regulatory structure - Since each state have its own regulators and there are totally 38 drug regulators in India, so if a drug is banned from one state it can be sold in another state.
• Jurisdictional issues - Many regulators has led to inconsistent enforcement of the law and jurisdictional issues.
• No focus on process - The Indian system is still oriented towards end products (medicines sold in the market) rather than processes.
• No transparency - There are no transparency requirements or mandatory disclosures of medicinal requirements in the law.
• Drug regulation being complex - Drug regulation section of the union health ministry find it difficult to regulate since the regulation process is complex.
• Lack of expertise - In the drug relation section of the union health ministry.
• Pharmaceutical industry over protecting public health - The government has greater interest in enabling the growth of the pharmaceutical industry than protecting public health.
• No law on drug recall - Even though government has been mulling for a binding a law on drug recall since 1976, there exists guild lines for drug recall.

Suggestions

• Amend the Drugs and Cosmetics Act: The primary goal is not to respond to substandard drugs retrospectively, but to prevent them altogether.
  • So, the DCA has to be amended to prevent the manufacturing of substandard drugs in the first place.
• Adopt Good Manufacturing Practices: Need to follow simple checks and balances, such as testing a raw material before putting it into a drug, buying raw material from a licensed manufacturer, and maintaining clean equipment, etc.
• Coordination and uniformity between various departments: Every state follows different standards to regulate the cases.
  • A mechanism should be built, where regulators should have proper communication links between them. Also, a set of uniform standards should be followed.
• Address the systemic issues in Drug regulation: There is a need to provide adequate training to the staff. Also, the vacancies should be filled immediately so that they are not overburdened.

Way forward

• Globally, it is evident that India’s pharmaceutical sector holds great power and development potential due to the country’s solid foundation in pharmaceutical third-party manufacture and the tenacity displayed particularly during the epidemic.
• With the help of thoughtful policy development, quality assurance, and an effective drug regulations regime, India can truly leverage its talented human resource to expand at a global scale.