Lok Sabha Question No. 1061 (UNSTARRED), answered on 2025-12-05
Subject: Proposals for Implementation SPI Scheme
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Tangella Uday Srinivas

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO.1061 TO BE ANSWERED ON THE 5 TH  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 year   | Export volume (metric tonnes)   | Export value (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 data

or  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 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

|   S. no. | Name of applicant                                                         | State / Union territory   | District           | Amount sanctioned (crore ₹)   | Amount disbursed (crore ₹)   | Status          |
|----------|---------------------------------------------------------------------------|---------------------------|--------------------|-------------------------------|------------------------------|-----------------|
|        1 | Tirupati Research& Development Pvt. Ltd.                                  | Andhra Pradesh            | Chittoor           | 20.00                         | 10.00                        | Approved        |
|        2 | Welzo Research& Development Pvt. Ltd.                                     | Himachal Pradesh          | Solan              | 19.53                         | 17.58                        | Approved        |
|        3 | Himachal Pharma Testing Lab Ltd.                                          | Himachal Pradesh          | Solan              | 17.87                         | 0.00                         | Approved        |
|        4 | Inducare Pharmaceuticals& Research Foundation                             | Maharashtra               | Pune               | 7.18                          | 6.46                         | Approved        |
|        5 | Tindivanam Pharma Park Association                                        | Tamil Nadu                | Tindivanam         | 15.88                         | 6.00                         | Approved        |
|        6 | Jeedimetla Effluent Treatment Ltd.                                        | Telangana                 | Medchal Malkajgiri | 20.00                         | 18.00                        | Approved        |
|        7 | Telangana Lifesciences Foundation (earlier Hyderabad Pharma city Limited) | Telangana                 | Hyderabad          | 18.87                         | 4.72                         | Approved        |
|        8 | Devbhumi Pharmaceutical Analytical Testing and Training Foundation        | Uttarakhand               | Haridwar           | 20.00                         | 18.00                        | Approved        |
|        9 | Pundrug                                                                   | Punjab                    | Mohali             | -                             | -                            | Rejected as the |

| 10.   | Brahma Kamal Biomed Foundation and Research Institute   | Uttarakhand   | Udham Singh Nagar   | -   | -   | applicant did not meet the eligibility criteria as per scheme guidelines   |
|-------|---------------------------------------------------------|---------------|---------------------|-----|-----|----------------------------------------------------------------------------|

## II. Revamped Pharmaceuticals Technology Upgradation Scheme

|   S. No. | State / Union territory                  | District     |   Number of applicant approved/rejected | Approved grant-in-aid (in lakh ₹)   | Status                                                                                   |
|----------|------------------------------------------|--------------|-----------------------------------------|-------------------------------------|------------------------------------------------------------------------------------------|
|        1 | Andhra                                   | Anakapalli   |                                       2 | 283.17                              | Approved                                                                                 |
|        1 | Pradesh                                  | Jaggayyapeta |                                       1 | 200.00                              | Approved                                                                                 |
|        1 |                                          | NTR          |                                       1 | 33.24                               | Approved                                                                                 |
|        1 |                                          | Prakasam     |                                       1 | 50.27                               | Approved                                                                                 |
|        1 |                                          | Srikakulam   |                                       1 | 200.00                              | Approved                                                                                 |
|        1 |                                          | 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 Nagar Haveli and Daman and Diu | Daman        |                                       1 | 120.94                              | Approved                                                                                 |
|        5 | Gujarat                                  | Ahmedabad    |                                      14 | 1,024.66                            | Approved                                                                                 |
|        5 |                                          | Vadodara     |                                       5 | 758.98                              | Approved                                                                                 |
|        5 |                                          | Banaskantha  |                                       1 | 45.04                               | Approved                                                                                 |
|        5 |                                          | Bharuch      |                                       4 | 244.64                              | Approved                                                                                 |
|        5 |                                          |              |                                       1 | -                                   | Rejected as the applicant did not meet the eligibility criteria as per scheme guidelines |
|        5 |                                          | Gandhinagar  |                                       4 | 390.32                              | Approved                                                                                 |
|        5 |                                          | Sabarkantha  |                                       6 | 377.39                              | Approved                                                                                 |

|    |                   | Kutch          | 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 Kashmir | Pulwama        | 2   | 100.53   | Approved                                                                                 |
| 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          |     |          | Approved                                                                                 |
|    |                   |                | 1   | 39.33    |                                                                                          |
|    |                   | Palghar        | 6   | 937.24   | Approved                                                                                 |
|    |                   |                | 1   | -        | Rejected as the applicant did not meet the eligibility                                   |

|    |             |                            |    |        | criteria 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 Singh Nagar |  3 | 332.86 | Approved                                                                                     |
|    |             | Sahibzada Ajit Singh Nagar |  1 | -      | Rejected as it was a duplicate application                                                   |
| 16 | Rajasthan   | Alwar                      |  1 | 63.83  | Approved                                                                                     |
| 16 |             | Jaipur                     |  1 | -      | Rejected as the applicant did not meet the eligibility criteria as per scheme guidelines     |
| 17 | Tamil Nadu  | Chennai                    |  1 | 115.88 | Approved                                                                                     |
| 17 |             | Kancheepuram               |  1 | 73.89  | Approved                                                                                     |
| 17 |             | Krishnagiri                |  1 | 200.00 | Approved                                                                                     |
| 17 |             | Thanjavur                  |  1 | 10.96  | Approved                                                                                     |
| 18 | Telangana   | Hyderabad                  |  1 | 105.84 | Approved                                                                                     |
| 18 |             | Medchal- Malkajgiri        |  3 | 325.73 | Approved                                                                                     |
| 18 |             | Sangareddy                 |  1 | -      | Rejected as the applicant did not meet the eligibility criteria as per the scheme guidelines |
| 19 | Uttar       | Meerut                     |  1 | 29.90  | Approved                                                                                     |
| 19 | Pradesh     | Gautam Buddha Nagar        |  1 | 35.70  | Approved                                                                                     |
| 20 | Uttarakhand | Dehradun                   |  2 | 160.40 | Approved                                                                                     |
|    |             | Haridwar                   |  8 | 741.61 | Approved                                                                                     |

|    |             | Udham Singh Nagar   |   2 |   138.92 | Approved   |
|----|-------------|---------------------|-----|----------|------------|
| 21 | West Bengal | Howrah              |   1 |    27.32 | Approved   |
| 21 |             | Kolkata             |   3 |   247.72 | Approved   |
| 21 |             | South 24 Parganas   |   2 |   223.52 | Approved   |
| 21 |             | Purba Bardhaman     |   1 |    70.4  | Approved   |

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