Context: Despite the rise in substandard drugs, India still lacks a national law on recalling drugs. India has never witnessed domestic or foreign pharmaceutical companies recall substandard or mislabelled drugs in India.
Is there a drug recall law in India?
- India has been mulling the creation of a mandatory recall law for substandard drugs that have failed to meet quality parameters since 1976, and yet no law exists that mandates such medicine be removed from the market to this day.
- Consequences when substandard drugs are not recalled: People, including children, are almost certainly dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market.
Issues plaguing India’s pharmaceutical industry and the drug regulatory mechanism:
India's pharmaceutical industry has been plagued by several issues which include-
- Weak regulatory framework: India's drug regulatory system is fragmented, with different agencies responsible for different aspects of drug regulation, such as drug approval, quality control, and pricing. This fragmentation often leads to duplication of efforts, delays, and inconsistencies in the regulatory process, making it difficult to ensure the safety and efficacy of drugs. Also, the incompetence of a regulator in one State can lead to adverse effects for patients in other states.
E.g., Drugs ordered to be recalled by a state drug controller in one State are sometimes found to be on sale in another State.
- Lack of accountability: Due to lack of expertise and accountability from bureaucracy and the apathy of pharma companies, the circulation of substandard drugs in the Indian market has been the modus operandi for decades. The awareness in the public that such drugs can have dangerous consequences for consumers, has come recently when the drug failures overseas brought attention to the issue.
- Jurisdictional issues: Due to the presence of many regulators, it has become a challenge to enforce the law due to jurisdictional issues.
- Lack of adequate quality control measures: Since drug manufacturing sector in India is highly fragmented, with a large number of small and medium-sized enterprises (SMEs) producing drugs. Many of these SMEs lack the resources and expertise to implement good manufacturing practices (GMP), resulting in poor quality control and the production of substandard drugs.
- Prevalence of counterfeit drugs in the market: Counterfeit drugs are often sold at a lower price, making them attractive to consumers who cannot afford genuine drugs. However, intake of such drugs can be ineffective or even dangerous.
- Issue of drug pricing: India has a complex system of drug pricing, with different pricing mechanisms for different categories of drugs. The lack of a transparent and rational drug pricing system often leads to high prices for essential drugs, making them unaffordable for many patients.
- Focus on Pharma industry over public health: The government has displayed a greater interest in enabling the growth of the pharmaceutical industry than protecting public health.
Government initiatives to strengthen the regulatory framework for drug recall:
India has taken some measures to strengthen the regulatory framework for drug recall. Some of these measures include:
- Establishment of the Central Drugs Standard Control Organization (CDSCO): In 2005, the CDSCO was established as the national regulatory body for drugs in India. The CDSCO is responsible for regulating the safety, efficacy, and quality of drugs in the country. In 2012, CDSCO proposed a set of draft recall guidelines, but it did not convert into a binding law.
- Introduction of the Drugs and Cosmetics (Amendment) Act, 2008: The amendment act provides for the recall of drugs that are found to be substandard, spurious, or not of standard quality. The act also empowers the CDSCO to issue directions for the recall of such drugs.
- Setting up of a Drug Alert System: The CDSCO has established a Drug Alert System to monitor adverse reactions to drugs and take necessary action to recall drugs that pose a risk to public health.
- Strengthening of quality control measures: The CDSCO has issued guidelines on good manufacturing practices (GMP) for drugs, and drug manufacturers are required to comply with these guidelines.
- Collaboration with international regulatory bodies: The CDSCO has signed several memoranda of understanding (MoUs) with international regulatory bodies to strengthen the regulatory framework for drugs. These MoUs provide for cooperation in areas such as information sharing, training, and capacity building.
Way Forward:
India's pharmaceutical industry and drug regulatory mechanism require a multifaceted approach that addresses the challenges, which include:
- Strengthen regulatory enforcement: CDSCO should be strengthened to ensure that it has the resources and expertise necessary to enforce regulations effectively. This includes increasing the number of inspectors and providing them with appropriate training and equipment.
- Centralising regulatory processes: To create an effective recall mechanism, the responsibility of recalling drugs has to be centralised, with one Central authority wielding the legal power to hold companies liable for failures to recall drugs from across the country. This would streamline the regulatory framework, simplify the drug approval process, reduce duplication and prevent issues of multiple jurisdictions in the regulatory process.
- Formulate Public health policy: Central government needs to have a comprehensive and clear public health policy that prioritises public health over profit.
- Improve quality control measures: The government should take measures to improve quality control measures for drugs. This includes rigorous implementation of good manufacturing practices (GMP) guidelines, providing technical support to SMEs to help them comply with GMP requirements, and strengthening the quality control infrastructure.
- Increase transparency and accountability: The drug regulatory system needs to be more transparent and accountable to the public. This includes making information on drug approval and recall processes more readily available to the public, and ensuring that regulatory decisions are based on sound scientific evidence.
- Strengthen international cooperation: The CDSCO should continue to collaborate with international regulatory bodies to share information and best practices and to learn from the experiences of other countries.
- Promote innovation: There is a need to create an environment that encourages innovation in the pharmaceutical industry. This includes providing incentives for research and development, promoting collaboration between industry and academia, and supporting the development of new technologies.