Central Idea

• The recent incidents of substandard and contaminated medicines in India have raised concerns about the quality and regulatory oversight in the pharmaceutical industry. While India takes pride in being the largest manufacturer of generic medicines globally, it is essential to address the persistent quality concerns to maintain its reputation and protect public health.

Tragic incidents highlighting quality concerns

• Digital Vision Contamination: In January 2020, 12 children in Jammu died after consuming contaminated medicine manufactured by Digital Vision, revealing the presence of diethylene glycol. Despite previous red flags from drug laboratories, another incident occurred six months later, leading to the death of a two-year-old consuming Cofset cough syrup from the same manufacturer.
• Nycup Syrup: In March 2021, Nycup syrup was found to have lower levels of the active ingredient, raising concerns about quality control. However, limited regulatory action hindered effective intervention against the manufacturer.

An overview of the drug regulation mechanism in India

• Central Drugs Standard Control Organization (CDSCO): The CDSCO, under the Ministry of Health and Family Welfare, is the central regulatory authority responsible for the approval, regulation, and control of pharmaceutical products in India. It plays a crucial role in granting licenses, conducting inspections, and monitoring drug manufacturing, import, and distribution.
• Drug Controller General of India (DCGI): The DCGI is the head of the CDSCO and holds the overall responsibility for drug regulation in India. The DCGI oversees the approval of new drugs, clinical trials, and the regulation of imported drugs.
• National Pharmaceutical Pricing Authority (NPPA): The NPPA regulates the prices of essential drugs in India to ensure affordability and accessibility. It monitors and controls the prices of scheduled medicines and sets guidelines for the pricing of pharmaceutical products.
• Pharmacovigilance Program of India (PvPI): PvPI is a national program that focuses on monitoring and reporting adverse drug reactions (ADRs) to ensure the safety of medicines. It encourages healthcare professionals and the public to report any suspected ADRs to a centralized database for analysis and evaluation
• Intellectual Property Rights (IPR) Protection: The regulatory framework includes provisions to protect intellectual property rights related to pharmaceutical inventions and innovations. This promotes research and development in the industry and encourages the introduction of new drugs.
• Manufacturing Standards: The CDSCO ensures that drug manufacturers in India adhere to good manufacturing practices (GMP) to ensure that drugs are produced under quality standards and are safe for use.
• Clinical Trials: The CDSCO regulates clinical trials in India to ensure that they are conducted ethically and with the safety of participants in mind. The CDSCO requires that clinical trials follow the guidelines of the International Conference on Harmonization (ICH).

Challenges in the Indian pharmaceutical industry

• Fragmented Regulatory Structure: With approximately 36 drug regulators in India, coordination and consistency in regulatory oversight become challenging. A consolidated and centralized regulatory body can mitigate the risk of regulatory capture and ensure common standards across states.
• Persisting Quality Concerns: Despite being the largest manufacturer of generic medicines globally, India has encountered quality issues. Recent inspections revealed that 48 drugs failed to meet quality standards, jeopardizing patient safety.
• Global Reputation at Stake: Observations from global regulators, such as the US FDA, indicate compliance issues in Indian pharmaceutical facilities, potentially tarnishing India’s image as a quality drug manufacturing country.
• Limited Regulatory Action: In some instances, regulatory action has been limited or challenging to implement due to various reasons, making it difficult to effectively address quality issues and hold manufacturers accountable.
• Insufficient Transparency and Accountability: The lack of transparency in the drug regulatory regime hinders public trust and confidence. Limited public disclosure of drug application reviews, inspection records, and past violations makes it challenging to evaluate the compliance and track record of manufacturers.
• Inspection and Enforcement Capacity: The sheer number of pharmaceutical manufacturing units in India, coupled with the large-scale inspection load, puts strain on the inspection teams under state drug controllers.

Way forward

• Regulatory Reforms: Amend the Drugs and Cosmetics Act (1940) and establish a centralized drugs database for effective surveillance. Consolidate regional regulators into a single regulatory body to minimize state-level patronage and influence networks. Implement common standards across states.
• Enhanced Transparency and Reporting: Publish comprehensive reports on drug testing laboratories’ findings and establish a public database of past violations, inspection records, and failure history. Introduce a national law on drug recall, empowering victims and imposing penalties on firms exporting spurious drugs.
• Strengthening the Central Drugs Standard Control Organisation (CDSCO): Provide statutory backing and establish a Central Drugs Authority as an independent body, ensuring effective regulation and enforcement.
• Industry Accountability: The pharmaceutical industry should focus on producing quality generic and innovative drugs, moving beyond generic manufacturing. Embrace zero-defect principles and prioritize public health.

Conclusion

• Addressing the challenges India’s pharmaceutical industry requires comprehensive reforms, including regulatory consolidation, transparency, enhanced inspections, and industry accountability. By prioritizing patient safety and ensuring the delivery of quality medicines, India’s pharmaceutical industry can reclaim its position as a global leader in drug manufacturing.

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