India now should focus on having its own pharmaceutical standards: FM

Sub : Eco

Sec :National Income

Context:

At the India Ideas Conclave, Finance Minister Nirmala Sitharaman emphasised the need for India to assert its identity in global standards, innovation, and ethical practices.

India’s Own Pharmaceutical Standards

Call for a Bharat FDA:
- India should establish its own pharmaceutical standards agency similar to the U.S. FDA.
- While U.S. FDA standards aid exports, a Bharat FDA can create global benchmarks rooted in India.
- “If we reach these benchmarks, Indian pharmaceutical products can be unsurpassed globally.”

Branding India as a Hub of Innovation

Quick Commerce and Gig Economy:
- Indian start-ups in quick commerce represent unique innovations not seen elsewhere.
- While supporting traditional retail, India should use its gig economy innovations to brand itself as a solution-provider for modern urban needs.
- This can scale Indian enterprises globally, creating a strong ‘Bharatiya’ identity in the international tech space.

Responsible Capitalism

India should aim to be a responsible capitalist country, guided by principles of dharma:
- Economic growth should be free of expansionism, exploitation, or aggression.
- Recontextualizing India’s values and characteristics is essential to building Brand Bharat.

The pharmaceutical industry in India

Notable achievements

The Indian pharmaceutical industry, often referred to as ‘the pharmacy of the world’, contributes immensely to global public health and promoting universal healthcare access.
India ranks 3rd worldwide for production by volume and 14th by value.
India is the largest provider of generic medicines globally, occupying a 20% share in global supply by volume.
- The pharmaceutical industry in India offers 60,000 generic brands across 60 therapeutic categories.
It is the leading vaccine manufacturer globally. 62% of the world’s vaccines comes from India.
- At least 70% of WHO’s vaccines (as per the essential immunisation schedule) are sourced from India.

Industry scenario:

Foreign Direct Investment (FDI)
- 100% FDI in the Pharmaceutical sector is allowed under the automatic route for greenfield pharmaceuticals.
- 100% FDI in the pharmaceutical sector is allowed in brownfield pharmaceuticals; wherein 74% is allowed under the automatic route and thereafter through the government approval route.
Market Size
- The pharmaceutical industry in India is valued at $50 bn in 2022-23 and exports accounting for 50% of the production.
  - It is expected to reach $65 bn by 2024 and to $130 bn by 2030.
Export
- India is a major exporter of Pharmaceuticals, with over 200+ countries served by Indian pharma exports.
- India supplies over 50% of Africa’s requirement for generics, ~40% of generic demand in the US and ~25% of all medicine in the UK.
- For the period 2021-22, export of drugs and pharma products stood at $24.6 bn compared to $24.44 bn as of 2020-21.
- The Indian pharma industry witnessed exponential growth of 103% during 2014-22 from $11.6 bn to $24.6 bn.

National Medical Devices (NMD) Policy, 2023:

Policy lays down a roadmap for accelerated growth of the medical devices sector to achieve the following missions viz, Access & Universality, Affordability, Quality, Patient Centred & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower.

Key features:

Regulatory Streamlining

Introduction of a “Single Window Clearance System” for licensing medical devices.
Integration of all relevant departments and organizations, such as:
- MeitY (Ministry of Electronics and Information Technology).
- DAHD (Department of Animal Husbandry & Dairying).
Balances patient safety with product innovation and research ease.

Enabling Infrastructure

Establishment of large medical device parks with world-class facilities near economic zones.
Implementation under the National Industrial Corridor Program and National Logistics Policy 2021, aligned with PM Gati Shakti.
Collaboration with state governments and the industry for better convergence with the medical device sector.

Facilitating R&D and Innovation

Focus on promoting Research & Development (R&D) in collaboration with the National Policy on R&D and Innovation in the Pharma-MedTech sector.
Establishment of:
- Centres of Excellence in academic and research institutions.
- Innovation hubs and ‘plug-and-play’ infrastructures.
- Support systems for start-ups.

Attracting Investments

Encourages private investment and Public-Private Partnerships (PPP) to boost the sector.
Complements existing programs like Make in India, Ayushman Bharat, Heal-in-India, and Start-up mission.
Facilitates funding from venture capitalists for the growth of the medical device industry.

Human Resources Development

Aims to create a skilled workforce for the medical device sector.
Programs for skilling, reskilling, and upskilling through the Ministry of Skill Development and Entrepreneurship.
Introduction of dedicated courses in medical devices to prepare manpower for futuristic technologies, manufacturing, and research.

Brand Positioning and Awareness Creation

About Central Drugs Standard Control Organization (CDSCO)

Purpose: The national regulatory body for drugs, medical devices, and cosmetics in India.
Comparison: For drugs, CDSCO is often referred to as India’s equivalent of the United States Food and Drug Administration (FDA) and for food and nutraceuticals, it is Food Safety and Standards Authority of India (FSSAI).
Authority: Functions under the provisions of the Drugs & Cosmetics Rules as the National Regulatory Authority (NRA) for the medical devices industry.
Ministry: Operates under the Ministry of Health & Family Welfare.
Leadership: Headed by the Drugs Controller General of India (DCGI).
Headquarters: Located in New Delhi.

Functions of CDSCO:

Under the Drugs and Cosmetics Act 1940, CDSCO is responsible for:

Approval of New Drugs.
Conduct of Clinical Trials.
Setting Standards for Drugs.
Monitoring Quality of Imported Drugs.
Coordination with State Drug Control Organizations.
Granting Licenses for critical drug categories in collaboration with state regulators, including:
- Blood and blood products.
- Intravenous (IV) Fluids.
- Vaccines.
- Sera.

Drugs Controller General of India (DCGI)

Role:
- Head of the CDSCO.
- Oversees approval of licenses for specialized drugs such as blood products, IV fluids, vaccines, and sera.
Responsibilities:
- Establishing standards for manufacturing, sales, import, and distribution of drugs in India.
- Ensuring regulatory compliance for safe and effective drug production and distribution.