Recommendations for Pharmaceuticals industry

The Indian pharma industry, along with biotechnology, has the potential to grow to $ 200 billion by 2025. CII recommends the following measures to tap this potential.

Short-term Measures

1. Industry Image and Quality

Every third pill swallowed in the US is from India, and the case is similar in many other countries. This clearly establishes the high quality of Indian drugs. However, the Indian pharma industry is battling an image issue, which is also affecting consumers. Government and industry need to work in partnership to build a positive image of the Indian pharma industry globally.

2. Regulatory Issues

For the last few years, the pharma industry has witnessed enormous transformations in regulatory policies aimed at improving the affordability and quality of healthcare. Industry welcomes these. However, the Government needs to ensure a stable regulatory environment, especially on regimens for protection of Intellectual Property (IP), pricing, clearances, trade, and export policies. Price control policies should consider the dependency of manufacturers on other countries like China, and price hikes for raw materials. This should lead to the revival of the Active Pharmaceutical Ingredients (API), bulk drug and formulation industry in India.

Medium-term Measures

1. Active Pharmaceutical Ingredients (API) and Bulk Drugs

India has about 10,500 bulk drugs and formulations manufacturing units and is a leading supplier of API globally. Bulk drug manufacturers face multiple challenges including higher cost of utilities, dependency on China for raw material, cumbersome environmental clearances, complexities in Government norms, and cheap imports. To make the Indian API industry more innovative and competitive, the need of the hour is to

Improve infrastructure within clusters and chemical parks.
Institute better mechanisms for environmental clearances.
Adopt a cluster-based common facility approach for promoting the API industry.
Incentivize MSMEs, who do not have the capacity to innovate, to collaborate with research institutions.
Notify public sector undertakings to manufacture critical API.

2. Ayushman Bharat

India has become a role model for the world by implementing Ayushman Bharat that plans to cover a population of 50 crores with affordable healthcare. To improve the efficacy of the scheme, it is necessary to devise a framework comprising protocols and standards for drug procurement, keeping affordability at the top, without compromising on the quality of drugs, to ensure the best clinical outcomes.

3. Exports

Continue to offer incentives on exports to support Indian industry in accessing new markets.
Benchmark incentives offered by other countries and accordingly frame incentives for Indian industry.
Simplify export procedures, remove duplication of clearances across various ministries.

4. Meet Skill Gaps

Set up skill universities in PPP mode in pharma clusters.
Create greater awareness for better implementation and adoption of the apprenticeship scheme.
Devise schemes to bring back the highly-skilled Indian manpower which has migrated to other countries.

5. Research & Development and Innovation

Revive the clinical research industry. Provide policy support to Indian Clinical Research Organizations (CROs) for participation in global clinical research.

Encourage innovation by increasing investment and collaborations, and catalyze foreign investment by creating a few success stories in the biopharma and pharma space.

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