Governance
Revamped Pharmaceuticals Technology Upgradation Assistance Scheme and UCPMP 2024
- 13 Mar 2024
- 8 min read
For Prelims: PTUAS Scheme, PMPDS, PLI scheme for Pharmaceuticals, Schedule M and WHO-GMP Standards
For Mains: Indian pharmaceutical industry, health, Government policies and interventions
Why in News?
The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, announces the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS).
- It aims to upgrade the technological capabilities of the pharmaceutical industry in alignment with global standards.
- Additionally, the DoP released the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. The code aims to ensure responsible marketing practices and curb misleading promotional activities.
What are the Key Highlights of the RPTUAS?
- Objective:
- The Department of Pharmaceuticals through RPTUAS aims to contribute to the growth of the pharmaceutical industry and ensure compliance with global manufacturing standards.
- Key Features:
- Broadened Eligibility Criteria:
- Expanded eligibility beyond Micro, Small, and Medium Enterprises (MSMEs) to include any pharmaceutical manufacturing unit with a turnover of less than Rs 500 crores.
- Preference remains for MSMEs, supporting smaller players in achieving high-quality manufacturing standards.
- Expanded eligibility beyond Micro, Small, and Medium Enterprises (MSMEs) to include any pharmaceutical manufacturing unit with a turnover of less than Rs 500 crores.
- Flexible Financing Options:
- Introduces subsidies on a reimbursement basis, offering more flexibility than the traditional credit-linked approach.
- Comprehensive Support for Compliance:
- Supports a wide range of technological upgrades in line with revised Schedule-M and World Health Organization (WHO)- Good Manufacturing Practices (GMP) standards, including HVAC systems, testing laboratories, clean room facilities, etc.
- Dynamic Incentive Structure:
- Offers incentives based on turnover, ranging from 20%, 15%, and 10% of investment under eligible activities for turnovers less than Rs. 50.00 crore, Rs. 50.00 to less than Rs. 250.00 crore, and Rs. 250.00 to less than Rs. 500.00 crore, respectively.
- State Government Scheme Integration:
- Allows integration with state government schemes to provide additional top-up assistance.
- Enhanced Verification Mechanism:
- Implements a robust verification mechanism through a Project Management Agency to ensure transparency and accountability.
- Broadened Eligibility Criteria:
Pharmaceuticals Technology Upgradation Assistance (PTUAS) Scheme
- PTUAS helps drug companies upgrade their facilities to produce medicines that meet global standards. It was launched in July 2022.
- Incentives under the Scheme:
- Interest Subvention:
- Up to a maximum of 5% per annum (6% for units owned and managed by Scheduled Castes and Scheduled Tribes) of interest subvention for the loan component eligible under the scheme, capped at Rs. 10 crore.
- This subsidy is applicable for a maximum period of 3 years on the reduced balance for loans sanctioned by scheduled commercial banks /financial institutions, both in the public and private sectors.
- Interest Subvention:
What are the Revised Schedule M and WHO-GMP Standards?
- The Union Health Ministry's notification in January 2024 introduced revisions to Schedule M of the Drugs and Cosmetics Rules, 1945, focusing on robust quality control measures for pharmaceutical and biopharmaceutical products.
- Schedule M prescribes Good Manufacturing Practices (GMP) for pharmaceutical products.
- GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was done in June 2005.
- With the amendment, the words ‘Good Manufacturing Practices’ (GMP) have been replaced with ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products’.
- GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was done in June 2005.
- Schedule M prescribes Good Manufacturing Practices (GMP) for pharmaceutical products.
- The revised Schedule M emphasizes adherence to GMP and incorporates requirements for premises, plant, and equipment. This ensures alignment with the World Health Organization (WHO) GMP Standards.
- GMP is the mandatory standard that builds and brings quality into a product by way of control on materials, methods, machines, processes, personnel, facility/environment, etc.
- The updated Schedule M introduces a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerised storage system for all drug products.
Recent Cases of Quality Issues in the Indian Medicines
- In December 2023 the data from the Central Drugs Standard Control Organisation (CDSCO), shows that at least 6% of cough syrup samples from 54 Indian manufacturers failed a mandatory quality test for export.
- Gambia, Uzbekistan, Cameroon, and the World Health Organization (WHO) expressed concerns following the deaths of children who had taken these medications.
- In April 2023, the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (USFDA) raised concerns over a drug-resistant bacteria strain allegedly linked to eye drops imported from India.
What are the Key Provisions of UCPMP 2024?
- Restrictions on Inducements:
- Medical representatives are prohibited from using inducements to gain access to healthcare professionals.
- Prohibition of Payments and Gifts:
- Companies are barred from offering cash, monetary grants, or pecuniary benefits to healthcare professionals or their family members.
- Pharmaceutical companies are forbidden from giving gifts or any pecuniary advantages to individuals qualified to prescribe or supply drugs.
- Evidence-Based Claims:
- Claims about a drug's usefulness must be supported by up-to-date evidence, and terms like "safe" and "new" must be used appropriately.
- Transparent CME Programs Only:
- Pharmaceutical companies can only engage with healthcare professionals (HCPs) for Continuing Medical Education (CME) through well-defined, transparent, and verifiable guidelines.
- Strict Compliance:
- The UCPMP will be circulated for strict compliance by all pharmaceutical companies and associations.
- All associations must constitute an Ethics Committee for Pharmaceutical Marketing Practices.
Pharmaceutical Industry in India
- Industry Scenario:
- The Economic Survey 2022-23 mentions that India is ranked 3rd worldwide in the production of pharma products by volume and 14th by value.
- The Pharma Industry is expected to reach USD 130 Bn by 2030. India is a major exporter of Pharmaceuticals, with over 200+ countries served by Indian pharma exports.
- The nation is the largest provider of generic medicines globally, occupying a 20% share in global supply by volume, and is the leading vaccine manufacturer globally.
- 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.
- India also accounts for approximately 60% of global vaccine demand. 70% of WHO’s vaccines are sourced from India.
- Schemes Related to the Pharma Sector:
UPSC Civil Services Examination, Previous Year Question (PYQ):
Mains:
Q. How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies? (2019)
