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

  1. The Food Safety Standards Authority of India (“FSSAI”) vide Order dated October 7, 2022 clarified that Food Business Operators are required to file separate applications for each variant of a product seeking endorsement of vegan logo on their products.
  2. The Ministry of Health and Family Welfare notified the Surrogacy (Regulation) Amendment Rules, 2022, vide Notification dated October 10, 2022. Following the amendment, in accordance with Rule 5 (2) of the Surrogacy (Regulation) Rules, the intending couple / woman is required to provide an affidavit, providing a guarantee of compensation for medical expenses, health issues, specified loss, damage, illness or death of surrogate mother and such other prescribed expenses incurred on a surrogate mother during the process of surrogacy. The said affidavit is required to be sworn before a Metropolitan Magistrate or a Judicial Magistrate of First Class, or an Executive Magistrate, or a Notary Public.
  3. The Ministry of Health and Family Welfare notified the Assisted Reproductive Technology (Regulation) Amendment Rules, 2022, vide Notification dated October 10, 2022. Following the amendment, in accordance with Rule 12 (2) of the Assisted Reproductive Technology (Regulation) Rules, the intending couple / woman is required to provide an affidavit, providing a guarantee of compensation for or specified loss, damage, complication or death of oocyte donor, during the process of oocyte retrieval. The said affidavit is required to be sworn before a Metropolitan Magistrate or a Judicial Magistrate of First Class, or an Executive Magistrate, or a Notary Public.
  4. The FSSAI vide Notification dated October 11, 2022 issued the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) First Amendment Regulations, 2022, setting out the procedure for grant of prior approvals for manufacture or import of non-specified food.
  5. The FSSAI vide Notification dated October 11, 2022 issued the Food Safety and Standards (Labelling and Display) Second Amendment Regulations, 2022, which sets out the declarations and labelling requirements in relation to pan masala and bread. These requirements come into force from May 1, 2023.
  6. The FSSAI has vide Order dated October 12, 2022 required food importers to avail of the facility of processing of the bill of entry, in advance, on the Food Import Clearance System, to facilitate faster clearance of imported food articles.
  7. Vide judgment dated October 12, 2022, in Vikas Rambal and Others v The State, the Madras High Court has held that the directors of a pharmaceutical company are liable for the production of sub-standard drugs.
  8. The Ministry of Health and Family Welfare notified the New Drugs and Clinical Trials (Third Amendment) Rules, 2022, vide Notification dated October 14, 2022. Further to this amendment:
  9. If no communication has been received from the Central Licensing Authority, within the prescribed period of 45 days, the registration of the Ethics Committees shall have been deemed to have been granted. In such an instance, the applicant has to undertake the filing of a prescribed form intimating the Central Licensing Authority of such deemed registration.
  10. If no communication has been received from the Central Licensing Authority, within the prescribed period of 90 days, the permission to conduct clinical trials shall have been deemed to have been granted. In such an instance, the applicant has to undertake the filing of a prescribed form intimating the Central Licensing Authority of such deemed approval.
  11. If no communication has been received from the Central Licensing Authority, within the prescribed period of 90 days, the permission to conduct bioavailability of bioequivalence study of a new drug shall have been deemed to have been granted. In such an instance, the applicant has to undertake the filing of a prescribed form intimating the Central Licensing Authority of such deemed approval.
  12. If no communication has been received from the Central Licensing Authority, within the prescribed period of 90 days, the permission to manufacture new drugs for clinical trials shall have been deemed to have been granted. In such an instance, the applicant has to undertake the filing of a prescribed form intimating the Central Licensing Authority of such deemed approval.
  13. If no communication has been received from the Central Licensing Authority, within the prescribed period of 90 days, the permission to manufacture unapproved active pharmaceutical ingredients or to manufacture the pharmaceutical formulations for test or analysis shall have been deemed to have been granted. In such an instance, the applicant has to undertake the filing of a prescribed form intimating the Central Licensing Authority of such deemed approval.
  14. The Central Drugs Standard Control Organisation has vide Notice dated October 21, 2022, required State Licensing Authorities to accept physical copies of applications for grant of Registration Certificate to sell, stock, exhibit, or offer for sale, or distribute a medical device including in vitro diagnostic medical devices.
  15. The FSSAI vide Notification dated October 27, 2022 issued the Food Safety and Standards (Food Products Standards and Food Additives) Second Amendment Regulations, 2022 by which the list of Enzymes derived from Genetically Modified Microorganisms (GMM) has been set out, which enzymes may be used for treatment or processing of raw materials, foods, or ingredients.
  16. The FSSAI vide Order dated November 10, 2022 clarified that sale of hemp seed and seed products (such as oil extracted from hemp seeds, hemp seed flour) be permitted on e-commerce websites.
  17. The Department of Pharmaceuticals vide Notification dated November 11, 2022 notified the Drugs (Prices Control) Amendment Order, 2022, by which the National List of Essential Medicines, 2022 has been notified.
  18. By its Order dated November 23, 2022, in State of Himachal Pradesh v Angejo Devi, the Supreme Court of India has observed that if any seized material contains ‘morphine' or ‘meconic acid' it is sufficient to establish that it is a narcotic drug / psychotropic substance under the Narcotic Drugs and Psychotropic Substances Act, 1985.
  19. The FSSAI has vide Notification dated December 13, 2022 issued the Food Safety and Standards (Advertising and Claims) Second Amendment Regulations, 2022 by which, amongst other requirements:
  20. Reduction of disease risk claims shall specify the number of servings of the food per day for the claimed benefit;
  21. Where the meaning of a trade mark, brand name or fancy name containing adjectives such as “natural”, “fresh”, “pure”, “original”, “traditional”, “authentic”, “genuine”, “real”, appearing in the labelling, presentation or advertising of a food is such that it is likely to mislead the consumer as to the nature of the food, in such cases a disclaimer shall be mentioned prominently on the front of pack of the label;
  22. Claims regarding the non-addition of sodium salts to a food, including “no added salt”, may be made, if certain conditions are met;
  23. Claims regarding the non-addition of additives including functional classes of additives to a food, may be made, if certain conditions are met.
  24. The Central Drugs Standard Control Organisation (“CDSCO”) has vide Notice dated December 22, 2022, required laboratories with capacity for testing medical devices and accredited by the National Accreditation Board for Testing and Calibration Laboratories, to submit an application vide Form MD-39. This exercise has been undertaken to enhance the testing capacity of medical devices and empanelment of private testing laboratories.
  25. The CDSCO has vide Notice dated December 23, 2022 required all manufacturers and importers of human vaccines to provide, for audit/inspection to the CDSCO, a summary of their pharmacovigilance system, along with details of the pharmacovigilance officer and any self-inspection report.
  26. Vide Press Release dated December 27, 2022, the Ministry of Health and Family Welfare has indicated that the CDSCO and the State Drugs Control Organization have commenced the joint inspection of drug manufacturing units, as per risk based approach, to ensure that such units are in compliance with the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, including the Good Manufacturing Practice issued thereunder.
  27. The National Pharmaceutical Pricing Authority has vide Order dated December 30, 2022, has (a) extended the timelines for prices fixed for Liquid Medical Oxygen and Oxygen Inhalation (Medicinal Gas) in Cylinder; and (b) extended the capping of trade margins at first point of sale for pulse oximeter, BP machine, nebulizer, digital thermometer, and glucometer, till March 31, 2023.
  28. The FSSAI vide Notification dated January 11, 2023 issued the Food Safety and Standards (Food Products Standards and Food Additives) First Amendment Regulations, 2023, by which standards for Basmati Rice (including Brown Basmati Rice, Milled Basmati Rice, Parboiled Brown Basmati Rice and Milled Parboiled Basmati Rice) have been specified. These regulations come into effect on August 1, 2023.
  29. The Bombay High Court on January 11, 2023 quashed the orders of the Maharashtra Food and Drug Administration cancelling Johnson and Johnson's license to manufacture its baby powder at the Mulund factory.

The Ministry of Health and Family Welfare vide Order dated January 16, 2023 has allowed for Aadhaar authentication to be undertaken for registration, licensing, or inspection of Food Business Operators.

Originally Published December 2022

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