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This edition of the JSA Healthcare Newsletter focuses on key developments undertaken in the Indian healthcare ecosystem for the month of December 2023.

Regulatory updates

CDSCO issues advisory to uphold drug quality through strict manufacturing standards

The Central Drugs Standard Control Organisation (“CDSCO”) issued an advisory guideline on December 5, 2023, alerting drug manufacturers to comply strictly with good manufacturing practices and licensing conditions. Emphasizing the critical role of excipients and active pharmaceutical ingredients (APIs) in ensuring drug quality, safety, and efficacy, the advisory urges the use of pharmaceutical-grade excipients in cough syrup production to prevent contamination, especially during increased usage in winters. Stakeholders are directed to ensure adherence to quality standards.

NMC issues a public notice banning e-cigarettes and heated tobacco products (HTPs)

The National Medical Commission (NMC) issued a public notice on December 15, 2023, notifying healthcare professionals about the ban on e-cigarettes and heated tobacco products (HTPs) under the Prohibition of Electronic Cigarettes (Production, manufacture, import, export, transport, sale, distribution, storage and advertisement) Act, (PECA), 2019. Affiliated professionals must refrain from researching or engaging in related activities without prior approvals from Directorate General of Health Services (Dte.GHS) and Ministry of Health and Family Welfare (MoHFW). The public notice also provides that healthcare professionals affiliated with National Medical Commission must comply with D.O. letter H.11013/03/2021-TC dated December 8, 2023.

CDSCO directs updating of label for a fixed-dose combination

The CDSCO issued a circular on December 18, 2023, addressing concerns over unapproved promotion of an anti-cold drug formulation for infants. The committee’s recommendation suggests restricting the use of fixed-dose combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCl IP 5mg drop/ml for children below 4 (four) years. Manufacturers are directed to update labels and promotional literature accordingly. All stakeholders are urged to notify action taken on such matter to the office.

Interesting Reads

e-pharmacies face backlash from the Madhya Pradesh Chemists’ Association

The Madhya Pradesh Chemists’ Association, in its annual meeting has called for action to be taken against the sale of online drugs, alleging that such e-pharmacies often sell adulterated and spurious drugs online. The President of the Association noted that as no mechanism was in place for regulation of e-pharmacies, no quality checks were in place to ensure the quality of the medicines being sold online and went on to urge other state associations as well as the Government of India, to address this concern at the earliest.

Rules of origin for medical sector

The rules of origin for the medical sector continues to remain a sticking point in ongoing discussions between the Governments of India and the United Kingdom in relation to the proposed Free Trade Agreement between the 2 (two) countries. Under this provision, the United Kingdom would not be able to dump goods from some third country in the Indian market by just putting a label on such goods and would have to undertake certain prescribed value addition in that product to export the product to India.

Healthcare advertisements most violative

In its half-yearly assessment of complaints, the Advertising Standards Council of India (“ASCI”), has reported that advertisements in the healthcare sector have been the most violative. The ASCI has concluded that the violations are largely owing to advertisements over social media, and often such advertisements have been violative of the provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

Gujarat becomes first state to issue online licenses of medicines

Gujarat has become the first state to issue online licenses to allopathic medicines through its newly launched FDCA-mDMLA mobile app. The mobile app will merge all the online platforms at one place for faster, real time access towards verification of the status of the application, as well as issue of the license. An Assistant Commissioner from the Gujarat Food and Drugs Control Administration will oversee the functioning of the mobile app and governance system.

Government of India mulls regulator for healthcare sector to facilitate insurance for all

The Government of India is considering setting up a regulator for the healthcare sector to facilitate affordable insurance coverage. Discussions between all stakeholders including the Ministries of Finance and Health, insurance companies, the IRDAI amongst others are envisaged in the near future

Case laws

Framing of policy for e-pharmacies

The High Court of Delhi in its recent order in Dr. Zaheer Ahmed v Preeti Sudan, Secretary, Union of India and Ors[1] has directed the Government of India to formulate a policy for sale of medicines by e-pharmacies within a period of 8 (eight) weeks, while acknowledging the delay in formulation and implementation of such a policy. The Court has also required the Joint Secretary dealing with such a policy to appear before the court if such policy has not been framed before the next date of hearing, being March 4, 2024.

Budgetary allocation and vacancy concerns in Maharashtra healthcare system

The High Court of Bombay, in the case of Khalil Ahmad Hasanmiya Wasta v. State of Maharashtra and Ors.[2], raised concerns regarding the underutilization of healthcare budget allocations and substantial staff vacancies in medical departments. The court highlighted the need to expedite recruitment processes to fill vacancies, emphasizing the adverse impact on healthcare facilities due to high number of unfilled positions. Additionally, the court requested detailed affidavits from authorities regarding past budgetary lapses and plans to address vacancies.

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