Stay updated with the latest developments in the life sciences and healthcare sectors with our February 2024 newsletter. Explore regulatory guidelines by CDSCO for drug sampling, online applications for medical device manufacturing, and more. Plus, delve into general updates including inaugurations, launches, and initiatives by healthcare leaders. Read now for comprehensive insights.

Industry Updates

1. Central Drugs Standard Control Organization (CDSCO) issued Regulatory Guidelines for the Sampling of Drugs, Cosmetics, and Medical Devices by Drugs Inspectors of Central and State Drug Authorities.

On February 9, 2024, the Drugs Controller General of India (DCGI) issued regulatory sampling guidelines to provide a framework for drug Inspectors at both the state and national levels, allowing for a more standardized and successful drug sampling process. These guidelines are mainly focused on utilizing available information & identified risks for the selection of samples and locations to cover a wide variety of drugs, cosmetics and medical devices available in the market from the manufacturing facility, wholesale outlet, retail outlet, government distribution channel, etc. in urban, suburban, and rural locations. These guidelines further provides for maintaining a centralized monthly NSQ/Spurious drug list and publishing it on the CDSCO website to avoid their further use.

The guidelines will be useful for effective surveillance of the quality & efficacy of drugs & cosmetics available in the market by adopting a uniform drug sampling methodology for drug inspectors under drug regulatory authorities of state and centre.

[Link here]

2.Central Drugs Standard Control Organization (CDSCO) launched an online application for Neutral Code for the manufacturing of medical devices for export purposes.

In order to simplify the process of submitting regulations, on February 12, 2024, CDSCO has notified that manufacturers can now apply for a Neutral Code to produce medical devices for export through the Online System for Medical Devices portal (https://cdscomdonline.gov.in). Applicants seeking a Neutral Code should apply through the online Portal following the checklist on the Portal.

The Central Licensing Authority will issue the Neutral Code to manufacturers under the Medical Devices Rules, 2017. Stakeholders are requested to submit Neutral Code applications only through the Online System for Medical Devices portal going forward.

[Link here]

3.On February 24, 2024, Central Drugs Standard Control Organization (CDSCO) launched Online Submission of Periodic Safety Update Reports (PSUR) Applications for Marketing Authorization of New Drugs/SNDs/FDCs/Biologicals /Veterinary.

To enhance the efficiency of regulatory submissions, the process for submitting PSURs related to the Marketing Authorization of New Drugs/Subsequent New Drugs (SND)/Fixed Dose Combinations (FDC)/Biologicals/Veterinary is now operational through the Sugam portal's online system at www.cdscoonline.gov.in. 

All PSUR applicants must use the online Portal and adhere to the checklist provided on the Portal. The option for offline submissions in hard copy or any other mode will not be available for processing starting from March 11, 2024.

[Link here]

4.Central Drugs Standard Control Organization (CDSCO) has issued the CDSCO Draft Guidance for Industry: Post Approval Changes in Biological Products: Quality Safety and Efficacy Documents.  

CDSCO has developed a preliminary Guidance for the industry titled "Post Approval Changes in Biological Products: Quality Safety and Efficacy Document" in collaboration with stakeholders to align with international guidelines, including those of the WHO, and contemporary practices followed by various regulatory bodies globally.

Suggestions, comments, or objections from stakeholders can be submitted within 45 days from the issuance of the Notice   which was published on February 28, 2024, via email to biological@cdsco.nic.in and vaccine-bio@dsco.nic.in.

The said guidance document aims to: 

(i)Facilitate the categorization of modifications made to biological products approved by CDSCO for import/manufacturing and marketing in India.

(ii)Furnish Marketing Authorization Holders (MA holders) with recommendations regarding the requisite data for a change, ensuring it is adequate for assessing the impact on the approved products' quality in terms of safety, efficacy, and/or effective utilization.

[Link here]

General Updates

1. The Union Minister of Health and Family Welfare, Dr Mansukh Mandaviya, inaugurated the new headquarters of the National Dental Commission (NDC) and laid the foundation stones for three Nursing Colleges in Andhra Pradesh and one in Jammu and Kashmir virtually on February 5, 2024. Further, Dr Mandaviya presided over the Memorandum of Understanding between the Dental Council of India and the Quality Council of India for the assessment and rating of undergraduate dental colleges and launched the National Dental Register under the National Health Digital Mission. Read more

2. Prof. S P Singh Baghel and Dr Bharati Pravin Pawar, Union Ministers of State for Health and Family Welfare, virtually launched the Kilkari programme, a Mobile Health (m-health) initiative for beneficiaries in Gujarat and Maharashtra on February 7, 2024. Mobile Academy, a free audio training course designed to enhance and refresh the knowledge of Accredited Social Health Activists (ASHAs) and improve their communication skills via their mobile phones, was also launched. Read more

3. The Union Minister for Health & Family Welfare and Chemicals & Fertilizers, Dr Mansukh Mandaviya, launched the AIIMS-SBI Smart Payment Card on February 12, 2024. The AIIMS-SBI Smart Payment Card will ensure hassle-free payments for treatment in AIIMS New Delhi. The Union Health Minister stated that the AIIMS Smart Payment Card will resolve the long-standing issue of patients from far-flung areas carrying cash to the hospital. He said that patients or their care-takers may simply obtain the card from the facilitation facilities throughout AIIMS, New Delhi, and then use it to pay at different counters. Read more

4. The Union Minister of Health and Family Welfare, Dr Mansukh Mandaviya, inaugurated Vivekananda Cancer & Super Speciality Extension Hospital of Vivekanand Medical Foundation and Research Centre in Latur, Maharashtra, on February 20, 2024. Speaking on the occasion, he noted that the preventative and promotive strategy of our conventional healthcare systems has played a vital role in the contemporary era, proving to be crucial in a crisis like the current epidemic. Read more

5. The Union Minister of Health and Family Welfare, Dr Mansukh Mandaviya, virtually inaugurated a "Regional Consultative Workshop on Research Priority for Providing Accessible and Affordable Healthcare for the Northeastern States of India" on February 21, 2024. The workshop is being jointly organized by the Department of Health Research, Ministry of Health and Family Welfare, Government of India; Indian Institute of Public Health, Shillong; and Indian Council of Medical Research - Regional Medical Research Centre, Dibrugarh. Read more

6. Shri Jagat Prakash Nadda, Member of Parliament, Rajya Sabha, in the presence of Dr Mansukh Mandaviya, Union Minister of Health and Family Welfare & Chemical and Fertilizers, inaugurated New Healthcare Facilities including Radiation Oncology, 128 Slice CT Scanner and a Liquid Medical Oxygen (LMO) plant at AIIMS Bilaspur, Himachal Pradesh on February 23, 2024. He also laid the foundation stone for a Vishram Sadan (night shelter) at AIIMS Bilaspur. Read more

Contributors to the newsletter:

• Nusrat Hassan, Managing Partner
• Pradnesh Warke, Partner
• Tanay Jha, Associate
• Khushi Shah, Associate