Dentons US LLP
04/24/2024 | News release | Distributed by Public on 04/25/2024 04:57
Lifesciences and Healthcare Newsletter - March 2024
April 24, 2024
Stay updated with the latest developments in the life sciences and healthcare sectors with our March 2024 newsletter. From the implementation of the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 to the transition towards online submissions for Periodic Safety Update Reports (PSURs) by the Central Drugs Standard Control Organization (CDSCO), we cover a spectrum of vital changes impacting the sector. Moreover, delve into the revamped schemes aimed at enhancing technological capabilities and strengthening the pharmaceutical industry.
Industry Updates
1. The Department of Pharmaceuticals notifies the new Uniform Code for Pharmaceutical Marketing Practices
On March 12, 2024, the Department of Pharmaceuticals notified the new Uniform Code for Pharmaceutical Marketing Practices("UCPMP"), 2024 superseding its erstwhile Uniform Code for Pharmaceutical Marketing Practices, 2014. Further, as per the notification, all associations have been requested to constitute an Ethics Committee for Pharmaceutical Marketing Practices ("ECPMP") and set up a dedicated UCPMP portal on their website and take the necessary steps towards implementation of the Code.
2. The Central Drugs Standard Control Organization ("CDSCO") mandates online applications of Periodic Safety Update Reports
On March 19, 2024, the CDSCO has facilitated streamlining of the regulatory submission procedure, the submission of applications of Periodic Safety Update Reports ("PSURs'") with respect to Marketing Authorization of Medical Devices/ In-vitro Devices is functional through the Online System for Medical Devices portal. All applicants submitting PSURs' shall now apply through the 'Online System for Medical Devices' as per checklist given in the Portal. The facility of offline submission of applications in hard copy or any other mode shall not be available for processing from April 1, 2024.
3. The Ministry of Health and Family Welfare ("MoHFW") implemented the provisions of the Jan Vishwas (Amendment of Provisions) Act, 2023
The MoHFW 2024, vide notification dated March 28, 2024, has implemented the amendments mentioned to the Drugs and Cosmetics Act, 1940, in the Jan Vishwas (Amendment of Provisions) Act, 2023 in force from December 31, 2024.
4. The Department of Pharmaceuticals announces the Revamped Pharmaceuticals Technology Upgradation Assistance ("RPTUAS") Scheme
On March 11, 2024, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers announced the RPTUAS Scheme. It is a significant step in the government's efforts to help upgrade the technological capabilities of the pharmaceutical industry and ensure its alignment with global standards.
The approval of the revised scheme follows a comprehensive review by the Scheme Steering Committee in light of the requirements of the revised Schedule-M of the Drugs and Cosmetics Rules, 1945 as issued by the Department of Health & Family Welfare on December 28, 2023. The revised guideline aims to support the pharmaceutical industry's up-gradation to the Revised Schedule-M & WHO-GMP standards, enhancing the quality and safety of pharmaceutical products manufactured in our country.
5. The Department of Pharmaceuticals notifies the revised Guidelines for the Scheme for Strengthening of Pharmaceuticals Industry
On March 14, 2024, the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers notified the revised Guidelines for the Scheme for "Strengthening of Pharmaceuticals Industry ("SPI"), with a financial outlay of ₹ 500 crores and tenure from FY 2021-2022 to FY 2025-26. The scheme has three sub-schemes- (i) Assistance to Pharmaceutical Industry for Common Facilities ("APICF") to provide infrastructure support for pharma MSMEs clusters for strengthening the infrastructure facilities; (ii) Promotion of Technology Upgradation Assistance Scheme ("PTUAS") to address the issues of technology upgradation of individual pharma MSMEs and (iii) Pharmaceutical and Medical Device Promotion and Development Scheme ("PMPDS") to create awareness, to conduct survey, studies, organize seminars, events.
General Updates
1. Dr. Mansukh Mandaviya, Union Minister of Health and Family Welfare virtually inaugurated 27 Greenfield Bulk Drug Park projects and 13 Greenfield Manufacturing Plants for Medical Devices under the Product Linked Incentive ("PLI") Scheme on March 2, 2024. Read More.
2. Dr. Mansukh Mandaviya, Union Minister of Health and Family Welfare launched the AYUSH-ICMR Advanced Centre for Integrated Health Research in AIIMS, on March 4, 2024. He also announced the joint initiatives between the Ministry of Health and Family Welfare and the Ministry of AYUSH which included Multicenter clinical trial on Anemia and the launch of Indian Public Health Standards ("IPHS") for AYUSH healthcare facilities. The Union Health Minister also inaugurated the 27th convocation of Rashtriya Ayurveda Vidyapeeth and the 29th National Seminar on 'Ayurvedo Amritanam' on the occasion. Read more.
3. On March 12, 2024, Dr. Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers & Health and Family Welfare launched the Credit Assistance Program for Jan Aushadhi Kendras. In this regard, he presided over the exchange of an MoU between Small Industries Development Bank of India ("SIDBI") and Pharmaceuticals and Medical Devices Bureau of India ("PMBI") and launched a website for credit assistance to Jan Aushadhi Kendras: Link here: https://jak-prayaasloans.sidbi.in/home. Read more.
Contributors to the newsletter:
- Nusrat Hassan, Managing Partner
- Pradnesh Warke, Partner
- Tanay Jha, Associate
- Khushi Shah, Associate