Proposals for Implementation of SPI Scheme

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Project proposals are received and considered for approval and rejection under two sub-schemes of Strengthening of Pharmaceuticals Industry (SPI) Scheme, namely, Assistance to Pharmaceutical Industry for Common Facilities and the Revamped Pharmaceuticals Technology Upgradation Scheme. Details of project proposals received, approved and rejected under each of these sub-schemes during the last four financial years, State- and district-wise in the country, including in the State of Andhra Pradesh, along with the reasons for rejection and the funds allocated and disbursed for approved projects during the said period, State- and district-wise, including in the State of Andhra Pradesh, are at Annex.

The volume and value of domestically manufactured pharmaceuticals (bulk drugs, drug intermediates, drug formulations, biologicals) exported during the last four years, year-wise are as under:

Source: Directorate General of Commercial Intelligence and Statistics

The Ministry of Health and Family Welfare has informed that manufacturers are required to obtain license for manufacturing of drugs for export as per the provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder, as well as to comply with the requirements of the importing country.

As and when inputs are received regarding cases involving issues related to quality, the same are investigated by the licensing authorities concerned for taking action under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, as the licensing authorities are empowered to take action in case of any violation to the provisions of the said Act and rules.

The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have taken several measures to ensure quality, safety and efficacy of medicines throughout the country, as stated below:

1. To assess regulatory compliance of drug manufacturing premises in the country, CDSCO, in collaboration with State regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022. This initiative has provided valuable insights into the ground reality of manufacturing practices and has led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework.
2. Schedule M to the Drugs Rules, 1945 has been revised vide Ministry of Health and Family Welfare’s notification dated 28.12.2023, in line with international standards {of the World Health Organization (WHO)}, and the same has come into effect for drug manufacturers with turnover more than ₹250 crore from 29.6.2024. However, for manufacturers having turnover of up to ₹250 crore, the timeline for implementation has been extended till 31.12.2025, vide notification dated 11.2.2025.
3. To require manufacturers to print or affix on packaging labels of top 300 brands of drug formulation products bar code or Quick Response (QR) code that stores data or information legible with software application to facilitate authentication, the Drugs Rules, 1945 were amended through notification dated 17.11.2022, which came into force from 1.8.2023, to provide for such printing or affixation in respect of the drug formulation products specified in Schedule H2 to the said rules.
4. On 18.1.2022, the Drugs Rules, 1945 were amended to provide that every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear QR code on its label at each level of packaging, that stores data or information readable with software application to facilitate tracking and tracing. Such stored data or information shall include the minimum particulars, including unique product identification code, batch number, manufacturing date, expiry date, etc.
5. On 11.2.2020, the Drugs Rules, 1945 were amended to provide with effect from 1.3.2021 that, along with the manufacturer, any marketer who sells or distributes any drug shall be responsible for the quality of that drug as well as other regulatory compliances under these rules.
6. The Drugs and Cosmetics Act, 1940 was amended through an amending Act of 2008 to provide for stringent penalties for manufacture of spurious and adulterated drugs. Certain offences were also made cognizable and non-bailable.
7. For speedy disposal of cases relating to offences under the Drugs and Cosmetics Act, 1940, State and Union Territory Governments have set up special courts.
8. To ensure efficacy of drugs, the Drugs Rules, 1945 have been amended to provide that applicants for grant of manufacturing license shall submit along with their application the result of bioequivalence study of oral dosage form of some drugs.
9. The Drugs Rules, 1945 have been amended to make it mandatory that applicants submit to the State Licensing Authority evidence of stability, safety of excipients, etc. before manufacturing license is granted by such authority.
10. The number of sanctioned posts in CDSCO has been increased significantly over the last 10 years.
11. For uniformity in the administration of the Drugs and Cosmetics Act, 1940, the Central regulator coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee meetings held with the State Drugs Controllers.

This information was given by Union Minister of State in the Ministry of Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply in Lok Sabha today.

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PC/GS/SG

Annexure

Annexure referred to in the reply to parts (a) to (c) of the LOK SABHA UNSTARRED Q. NO. 1061 for answer on 5.12.2025, raised by Shri Tangella Uday Srinivas, regarding Proposals for Implementation SPI Scheme

Details of project proposals received, approved and rejected under each sub-scheme of the Strengthening of Pharmaceuticals Industry (SPI) scheme during the last four financial years, along with the reasons for rejection and the funds allocated and disbursed for approved projects

1. Assistance to Pharmaceutical Industry for Common Facilities sub-scheme

1. Revamped Pharmaceuticals Technology Upgradation Scheme

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