The Central Government has introduced a Bill to amend the Drugs and Cosmetics Act, 1940, aiming to strengthen pharmaceutical regulation in India and ensure the safety and efficacy of medicines.
Introduction
India, known as the "pharmacy of the world," has played a critical role in ensuring global healthcare accessibility through affordable generic medicines. Government initiatives, such as the Pradhan Mantri Jan Aushadhi Yojana, have saved consumers an estimated ₹30,000 crore by 2024. Despite this, concerns persist regarding the quality of drugs, regulatory oversight, and public health safety. India’s pharmaceutical regulatory framework, fragmented between central and state authorities, highlights the need for urgent reforms to ensure affordability, quality, and global competitiveness.
Current Status of Pharmaceutical Regulation in India
Regulatory Bodies:
Central Drugs Standard Control Organization (CDSCO): Established in 1940, it ensures safety, efficacy, and quality of drugs, cosmetics, and medical devices.
National Pharmaceutical Pricing Authority (NPPA): Formed in 1994, it regulates and monitors the prices of essential medicines under the Drugs Price Control Order (DPCO).
Department of Chemicals and Petrochemicals (DCP): Handles policy planning for pharmaceuticals, promoting sectoral growth.
State Drug Regulatory Authorities: Oversee licensing and quality control of drugs at the state level, often leading to fragmented enforcement.
Pharmacovigilance Programme of India (PvPI): Monitors adverse drug reactions (ADRs) but remains underutilized.
Key Policies and Regulations:
Drugs and Cosmetics Act, 1940: Governs drug import, manufacture, and sale, but enforcement varies across states.
Good Manufacturing Practices (GMP): Mandated under Schedule M to ensure high-quality production.
Patent Act, 1970 (amended in 2005): Supports generic drug production while balancing intellectual property rights.
Schedule Y: Provides guidelines for conducting clinical trials.
Drugs Price Control Order (DPCO): Regulates drug pricing to ensure affordability.
Challenges in Pharmaceutical Regulation
1. Proliferation of Substandard and Counterfeit Drugs:
Weak enforcement allows low-quality drugs to infiltrate markets, especially in rural areas.
WHO estimates 10% of drugs in low- and middle-income countries are substandard or falsified.
Recent cases like Indian-made cough syrups linked to child fatalities in Gambia highlight the issue.
Small manufacturers dominate the market, often evading quality checks.
Regulatory gaps exacerbate public health risks, particularly among vulnerable populations.
2. Erosion of International Trust in Exports:
Inconsistent adherence to global standards undermines India's pharmaceutical exports.
The US FDA issued over nine warning letters to Indian manufacturers in 2022.
Cases like the Ranbaxy scandal dent India's reputation as a reliable exporter.
WHO-GMP compliance is limited, with only 19% of Indian manufacturing units certified.
Export rejections hinder economic growth and global market access.
3. Antimicrobial Resistance (AMR):
Unregulated production and overuse of antibiotics drive AMR, a critical health threat.
Nearly 64% of antibiotics sold in India are unapproved, exacerbating resistance.
AMR increases mortality, weakens healthcare systems, and poses a global challenge.
Surveillance of antibiotic use remains inadequate despite rising resistance trends.
4. Inadequate Pharmacovigilance:
India contributes only 2% to the global ADR database, reflecting poor surveillance.
PvPI lacks integration with private hospitals and rural health centers.
The recall of ranitidine in 2019 highlighted gaps in ADR tracking.
Limited post-marketing surveillance compromises drug safety monitoring.
Insufficient data analytics tools impede early detection of drug risks.
5. Environmental Impact of Pharmaceutical Waste:
Poor waste disposal practices contaminate ecosystems and water bodies.
Rivers like the Yamuna rank among the most polluted globally due to pharmaceutical effluents.
Antibiotic pollution accelerates AMR, with India as a major contributor.
Weak enforcement of effluent treatment standards aggravates environmental damage.
Lack of green manufacturing practices leads to unsustainable production.
Measures to Enhance Pharmaceutical Regulation
1. Streamlining Regulatory Frameworks:
Merge central and state agencies into a Centralized Drug Authority for cohesive oversight.
Standardize approval and monitoring processes to eliminate redundancies.
Learn from centralized systems like the US FDA for uniform enforcement.
Implement clear accountability mechanisms for regulatory bodies.
Introduce real-time compliance tracking to improve governance.
2. Strengthening Pharmacovigilance Systems:
Expand PvPI to include private hospitals, rural clinics, and online pharmacies.
Use AI and data analytics for early ADR detection and risk prediction.
Establish consumer-friendly platforms for ADR reporting, such as mobile apps.
Integrate pharmacovigilance with international databases for better insights.
Provide financial and technical support to PvPI for capacity building.
3. Enforcing GMP and Compliance Standards:
Conduct periodic audits of manufacturing facilities to ensure GMP adherence.
Introduce QR codes on drug packaging to enhance supply chain traceability.
Impose stricter penalties for GMP violations to deter non-compliance.
Offer tax incentives for manufacturers adopting WHO-GMP standards.
Develop training programs for regulatory staff to align with global best practices.
4. Regulating Online Pharmacies:
Mandate registration of e-pharmacies with Aadhaar-enabled verification.
Use AI tools to monitor digital transactions and flag irregularities.
Enforce strict penalties for selling counterfeit or unapproved drugs online.
Create awareness campaigns to educate consumers about safe online purchases.
Align online pharmacy regulations with global frameworks for consistency.
5. Encouraging Sustainable Practices:
Subsidize clean technologies to promote green pharmaceutical manufacturing.
Enforce stringent effluent treatment norms to minimize environmental damage.
Collaborate with CPCB and MoEFCC for regular inspections and monitoring.
Encourage R&D for biodegradable drug formulations and eco-friendly practices.
Establish pharmaceutical waste management facilities across major production hubs.
Conclusion
India’s pharmaceutical sector is at a critical juncture, requiring comprehensive reforms to address regulatory, quality, and environmental challenges. A unified regulatory framework, robust pharmacovigilance, and strict adherence to global standards will ensure drug safety and affordability. Embracing technological innovations, sustainable practices, and public awareness campaigns can further strengthen the sector. With proactive measures, India can cement its position as a leader in global healthcare while safeguarding domestic health outcomes.
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