Anupriya Patel Highlights Key Policy Measures and Global Collaborations in Rajya Sabha

India Strengthens Pharmaceutical Price Regulation and International Regulatory Cooperation.

The National Pharmaceuticals Pricing Policy (NPPP), 2012, plays a crucial role in ensuring the affordability and accessibility of essential medicines in India. The policy establishes a robust framework for the regulation of drug prices, balancing consumer interests with the need to maintain a competitive pharmaceutical industry. Additionally, the Central Drugs Standard Control Organisation (CDSCO) has been actively collaborating with international regulatory agencies to strengthen global cooperation in drug safety, quality, and approvals.

Union Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, provided these updates in a written reply in the Rajya Sabha today, underscoring India’s commitment to affordable medicines and international regulatory alignment.

The NPPP, 2012, notified by the Department of Pharmaceuticals on December 7, 2012, introduced a market-driven approach to drug pricing. The policy focuses on:

1. Essentiality-Based Regulation:

• Price control applies only to medicines categorized as essential under the National List of Essential Medicines (NLEM).
• This ensures that critical drugs remain affordable for the public.

2. Regulation of Finished Formulations, Not Bulk Drugs:

• The policy regulates the prices of final pharmaceutical products used by consumers (tablets, syrups, injections, etc.), rather than upstream products like bulk drugs or intermediates.
• This ensures price control is directly linked to patient affordability.

3. Market-Based Pricing (MBP) Instead of Cost-Based Pricing:

• The Drugs (Prices Control) Order, 1995, relied on cost-based pricing to regulate drug prices.
• The NPPP, 2012, replaced this with market-based pricing, where the ceiling price is determined based on the simple average of prices of all brands having at least 1% market share.
• This transition allows competitive pricing while ensuring affordability.

The full Gazette notification on NPPP, 2012, is available here.

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India Expands Global Cooperation in Drug Regulation

Alongside pharmaceutical price regulation, India is actively enhancing regulatory cooperation with international drug control agencies. The Central Drugs Standard Control Organisation (CDSCO) has signed agreements and Memorandums of Understanding (MoUs) with multiple nations and global regulatory bodies.

Countries and Agencies Partnering with CDSCO:

CDSCO has established partnerships with regulatory authorities in: ✅ Afghanistan ✅ Argentina ✅ Brazil ✅ Denmark ✅ Dominican Republic ✅ Ecuador ✅ Germany ✅ Guyana ✅ Japan ✅ Netherlands ✅ Russian Federation ✅ Suriname ✅ Sweden ✅ Ukraine ✅ United Kingdom ✅ United States of America ✅ Drug Regulatory Authority of BRICS (Brazil, Russia, India, China, South Africa)

Purpose of International Regulatory Cooperation:

• Harmonization of Drug Standards: Aligning drug safety and quality measures with global best practices.
• Expedited Drug Approvals: Faster clearance for new medicines through mutual recognition agreements.
• Pharmacovigilance and Drug Safety: Strengthening post-market surveillance of medicines to track adverse effects.
• Facilitation of Exports: Ensuring Indian pharmaceutical exports meet international regulatory requirements.

These collaborations enhance India's role as a global pharmaceutical hub, ensuring high-quality medicines for both domestic and international markets.

The National Pharmaceuticals Pricing Policy, 2012, has reinforced India’s commitment to affordable healthcare by regulating essential drug prices based on market trends. Simultaneously, the expansion of global regulatory cooperation positions India as a key player in the international pharmaceutical landscape. The government’s proactive measures not only protect consumer interests but also support the pharmaceutical industry in aligning with global standards.

With continued reforms and collaborations, India is strengthening its position as a leader in pharmaceutical regulation, accessibility, and innovation.