Welcome to the latest edition of our monthly Lifesciences and Healthcare Newsletter for January 2024. 

Industry Updates

1. Central Drugs Standard Control Organization (CDSCO) launches National Single Window System (NSWS) Portal

On January 1, 2024, CDSCO launched the NSWS Portal to streamline the process for the Pharma and Medical Devices sector. The portal is independent from the SUGAM Portal and the cdscomdonline portal. Initially the following three activities under the Medical Device Rules, 2017 were made live:

1. Application of grant of Certificate of Registration of a Notified Body – Form MD-01.
2. Application for License to Manufacture Medical Devices for the Purpose of clinical investigations, test, evaluation, demonstration, training – Form MD-12.
3. Application for License to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training – Form MD-16.

Further, the existing cdscomdonline for the said activities has been disabled from January 15, 2024.

[Link here]

2. The Indian Pharmacopoeia Commission (IPC) has released the Addendum 2024 to the Indian Pharmacopoeia (IP) 2012

The IPC has published the Addendum 2024 to the IP 2012, in order to further strengthen the standards of the drugs being manufactured and/or marketed in India. Dr Mansukh Mandaviya, Union Minister of Health and Family Welfare and Chemicals & Fertilizers released the Addendum on January 7, 2024, at CDSCO Bhawan, Indore. This Addendum shall be effective from July 1, 2024, so as to ensure compliance and implementation of the new standards included therein.

[Link here]

3. Evaluation of certain pre 1988 permitted Fixed Dose Combination de novo for manufacture for sale in country.

The expert committee under the Chairmanship of Dr. M.S. Bhatia has revisited the landscape of certain pre-1988 Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country. After banning 14 fixed dose combinations (FDCs) last year from a list of 19, which were licensed prior to the year 1988 for manufacture for sale in the country without due approval from the Central Licensing Authority. On January 11, 2023, the expert committee recommended the generation of data including on safety and efficacy for three FDCs and has considered two FDCs as rational with certain conditions.

[Link here]

4. Central Drugs Standard Control Organization (CDSCO) launches additional Forms on the National Single Window System (NSWS) Portal

CDSCO launched additional Forms on the NSWS Portal. The following Forms have been made live from January 16, 2024:

1. Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis – CT-10.
2. Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study- CT-12.
3. Application for grant of permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study – CT-13.
4. Application for grant of license to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis – CT-16.

Further, Form 12 – ‘Application for license to import drugs for purpose of examination, test or analysis’ has been made live from January 24, 2024. The existing SUGAM Portal for the said activities has been disabled from February 10, 2024.

[Link here]

General Updates

1. Dr. Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers & Health and Family Welfare  inaugurated the Accident & Emergency Block, Lady Hardinge Kriplani Hospital, New Hostel Block, Atal Bihari Vajpayee Institute of Medical Research (ABVIMS) & Dr. RML Hospital, Sports Injury Centre, Vardhman Mahavir Medical College (VMMC) & Safdarjung Hospital and Academic block & New Hostel Block, Rajkumari Amrit Kaur College of Nursing on January 8, 2024. Read more

2. On January 12, 2024, Dr. Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers & Health and Family Welfare virtually inaugurated the permanent campus of National Institute of Pharmaceutical Education and Research (NIPER) in Guwahati, Assam today and also laid the foundation stone of NIPER Hyderabad and NIPER Raebareli. In a significant boost to healthcare infrastructure in the Northeast, Dr Mandaviya dedicated five new facilities in the Regional Institute of Paramedical and Nursing Science (RIPANS) in Aizawl, Mizoram to the nation. He also laid the foundation stone for over 80 units of health infrastructure in 7 Northeastern states including Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland, and Tripura under the Pradhan Mantri – Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) and the National Health Mission (NHM).  Read more

3. On January 18, 2024, the Union Cabinet approved the Memorandum of Understanding (MoU) between India and Ecuador on cooperation in the field of Medical Products Regulation. The Memorandum of Understanding will facilitate better understanding of the regulatory aspects between the two sides and will help in increased cooperation in the field of medical products regulation and better coordination in international fora. Read more

4. On January 18, 2024, the Union Cabinet approved the Memorandum of Understanding between India Dominican Republic on cooperation in the field of Medical Products Regulation. The MoU will promote exchange of information and cooperation in areas pertinent to medical products and relevant administrative and regulatory matters within the jurisdiction of the parties. In order to tackle issues of substandard, falsified medicines moving in the international markets, interaction amongst regulatory agencies is facilitated through signing of the MoU. Read more

5. The Union Cabinet approved the Memorandum of Intent (MoI) between India and Netherlands on cooperation in the field of Medical products Regulation on January 18, 2024. The MoI seeks to establish a framework for fruitful cooperation and exchange of information between the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health, Welfare and Sport, Kingdom of the Netherlands on behalf of Medicines Evaluation Board, Health and Youth Care Inspectorate, Central Committee on Research Involving Human Subjects in matters relating to medical products regulation in line with their international responsibilities. Read more

6. Dr. Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers & Health and Family Welfare  virtually inaugurated a Super Specialty Block at Ganesh Shankar Vidyarthi Memorial Medical College in Kanpur, Uttar Pradesh today. He also laid the foundation stone for an All India Institute of Speech and Hearing (AIISH) Satellite Centre in Kanpur on January 24, 2024. Read more

Contributors to the newsletter:

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