Parliament Question: Proposals for Implementation SPI Scheme

GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS LOK SABHA UNSTARRED QUESTION NO.1061 TO BE ANSWERED ON THE 5TH DECEMBER, 2025 Proposals for Implementation SPI Scheme

1061. Shri Tangella Uday Srinivas:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

(a) the number of project proposals received, approved, and rejected under each component of the Strengthening of Pharmaceuticals Industry (SPI) Scheme during the last four financial years, State-wise and district/cluster-wise in the country, including Andhra Pradesh;

(b) the reasons for rejection of proposals;

(c) the funds allocated and disbursed for approved projects during the same period, Statewise and cluster-wise, especially for Andhra Pradesh;

(d) the total volume and value of domestically manufactured pharmaceuticals exported during the last four years, year-wise;

(e) whether the Government is aware of the fact that pharmaceutical consignments from the country failed quality tests in foreign markets and if so, the details of such cases; and

(f) the corrective actions taken/proposed to strengthen quality control and regulatory compliance? ANSWER THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SMT. ANUPRIYA PATEL)

(a) to (c): Project proposals are received and considered for approval and rejection under two sub-schemes of 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.

(d): 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:Financial Export volume Export value year (metric tonnes) (crore ₹) 2020-21 6,42,718 1,74,064 2021-22 10,72,475 1,74,955 2022-23 10,55,352 1,94,254 2023-24 12,24,616 2,19,441 2024-25 12,40,537 2,45,966

Source: Directorate General of Commercial Intelligence and Statistics

(e) and (f): 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:

(i) 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.

(ii) 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.

(iii) 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.

(iv) 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 dataor information shall include the minimum particulars, including unique product identification code, batch number, manufacturing date, expiry date, etc.

(v) 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.

(vi) 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.

(vii) 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.

(viii) 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.

(ix) 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.

(x) The number of sanctioned posts in CDSCO has been increased significantly over the last 10 years.

(xi) 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.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 I. Assistance to Pharmaceutical Industry for Common Facilities sub-scheme State / Amount Amount S.

Name of applicant Union District sanctioned disbursed Status no. territory (crore ₹) (crore ₹)

1. Tirupati Research & Andhra Chittoor 20.00 10.00 Approved Development Pvt. Pradesh Ltd.

2. Welzo Research & Himachal Solan 19.53 17.58 Approved Development Pvt. Pradesh Ltd.

3. Himachal Pharma Solan 17.87 0.00 Approved Testing Lab Ltd.

4. Inducare Maharashtra Pune 7.18 6.46 Approved Pharmaceuticals & Research Foundation

5. Tindivanam Pharma Tamil Nadu Tindivanam 15.88 6.00 Approved Park Association

6. Jeedimetla Effluent Telangana Medchal 20.00 18.00 Approved Treatment Ltd. Malkajgiri

7. Telangana Hyderabad 18.87 4.72 Approved Lifesciences Foundation (earlier Hyderabad Pharma city Limited)

8. Devbhumi Uttarakhand Haridwar 20.00 18.00 Approved Pharmaceutical Analytical Testing and Training Foundation

9. Pundrug Punjab Mohali — — Rejected as the10. Brahma Kamal Uttarakhand Udham — — applicant Biomed Foundation Singh did not meet and Research Nagar the Institute eligibility criteria as per scheme guidelines II. Revamped Pharmaceuticals Technology Upgradation Scheme State / Number of Approved S. No. Union District applicant grant-in-aid Status territory approved/rejected (in lakh ₹) 1 Andhra Anakapalli 2 283.17 Approved Pradesh Jaggayyapeta 1 200.00 Approved NTR 1 33.24 Approved Prakasam 1 50.27 Approved Srikakulam 1 200.00 Approved Krishna 2 — Rejected as the applicant did not meet the eligibility criteria as per scheme guidelines 2 Assam Kamrup 1 46.87 Approved 3 Bihar Muzaffarpur 1 3.94 Approved 4 Dadra and Daman 1 120.94 Approved Nagar Haveli and Daman and Diu 5 Gujarat Ahmedabad 14 1,024.66 Approved Vadodara 5 758.98 Approved Banaskantha 1 45.04 Approved Bharuch 4 244.64 Approved 1 — Rejected as the applicant did not meet the eligibility criteria as per scheme guidelines Gandhinagar 4 390.32 Approved Sabarkantha 6 377.39 ApprovedKutch 1 200.00 Approved Mehsana 9 739.24 Approved Panchmahal 1 58.27 Approved Rajkot 3 251.24 Approved Surat 3 216.18 Approved 1 — Rejected as the applicant did not meet the eligibility criteria as per scheme guidelines Surendranagar 2 26.72 Approved Valsad 2 137.12 Approved 6 Haryana Ambala 1 128.09 Approved Faridabad 1 200.00 Approved Faridabad 1 — Rejected as the applicant did not have drug license Gurugram 1 85.97 Approved 7 Himachal Solan 27 2,772.14 Approved Pradesh Sirmaur 15 1,598.54 14 approved;

one rejected as it was a duplicate application 8 Jammu and Pulwama 2 100.53 Approved Kashmir 9 Karnataka Bengaluru 4 538.93 Approved Dharwad 2 194.28 Approved Uttara Kannada 1 79.97 Approved 10 Kerala Malappuram 1 157.67 Approved Palakkad 1 49.47 Approved Thrissur 1 70.40 Approved 11 Madhya Bhopal 1 103.36 Approved Pradesh Dhar 1 67.95 Approved Indore 4 610.90 Approved 12 Maharashtra Akola 1 200.00 Approved Nagpur 2 206.31 Approved Nasik 1 39.33 Approved Palghar 6 937.24 Approved 1 — Rejected as the applicant did not meet the eligibilitycriteria as per scheme guidelines Pune 5 420.58 Approved Raigad 5 571.52 Approved Ratnagiri 1 13.18 Approved Thane 7 517.67 Approved 13 Odisha Cuttack 1 66.34 Approved 14 Puducherry Puducherry 2 69.18 Approved 15 Punjab Amritsar 1 11.07 Approved Ludhiana 1 35.56 Approved Sahibzada Ajit 3 332.86 Approved Singh Nagar Sahibzada Ajit 1 — Rejected as it Singh Nagar was a duplicate application 16 Rajasthan Alwar 1 63.83 Approved Jaipur 1 — Rejected as the applicant did not meet the eligibility criteria as per scheme guidelines 17 Tamil Nadu Chennai 1 115.88 Approved Kancheepuram 1 73.89 Approved Krishnagiri 1 200.00 Approved Thanjavur 1 10.96 Approved 18 Telangana Hyderabad 1 105.84 Approved Medchal- 3 325.73 Approved Malkajgiri Sangareddy 1 — Rejected as the applicant did not meet the eligibility criteria as per the scheme guidelines 19 Uttar Meerut 1 29.90 Approved Pradesh Gautam Buddha 1 35.70 Approved Nagar 20 Uttarakhand Dehradun 2 160.40 Approved Haridwar 8 741.61 ApprovedUdham Singh 2 138.92 Approved Nagar 21 West Howrah 1 27.32 Approved Bengal Kolkata 3 247.72 Approved South 24 2 223.52 Approved Parganas Purba 1 70.40 Approved Bardhaman *****