INTRODUCTION
This newsletter highlights the key developments and measures as well as other major developments in the Indian healthcare and pharma sector for the months of June - July 2023.
RECENT LEGAL & REGULATORY DEVELOPMENTS
Delhi High Court directs the Government of India to submit details of deliberations in relation to draft rules to regulate e-pharmacies
The Delhi High Court in a recent order has directed the Government of India ("GOI") to submit the outcome of its consultation with stakeholders on the draft amendment1 to the Drugs and Cosmetics Rules, 1945 which propose to regulate e-pharmacies. This order comes pursuant to the petitions filed by the South Chemists and Distributors Association ("SCDA") and others2 seeking a ban on online sale of drugs by pharmacies.
Previously, in an order dated December 12, 2018 ("Interim Order"), the Delhi High Court had injuncted e-pharmacies from selling any medicines online if they did not possess licenses required to be obtained under the Drugs and Cosmetics Act, 1940 ("Drugs Act"). The court has remarked that the pendency of the above petitions will not affect the GOI's power to take action against companies who are violating the Interim Order.3
SCDA urges state drug regulators to take action against e-pharmacies
A letter has been issued by the SCDA urging drug regulators to take action against e-pharmacies who are in violation of the Interim Order.4 Further, SCDA has also claimed that certain pharmacies are consistently violating the provisions of the notification dated March 26, 2020,5 issued by the Ministry of Health and Family Welfare, during the outbreak of the Covid-19 pandemic.
The notification allowed pharmacies which were holding a valid license under the Drugs Act to undertake, in revenue districts where they held the license, door delivery of medicines specified in Schedule H of the Drugs Act such as Candesartan (medication to treat high blood pressure), Artemether (medication to treat malaria) etc. However, as per the SCDA, pharmacies have been: (a) selling medicines specified in Schedule H1 of the Drugs Act; (b) delivering medicines outside their respective revenue district; and/or (c) engaging logistics companies for delivery of medicines which do not hold the required licenses under the Drugs Act.
Gujarat Food and Drug Control Administration cancels 394 product licenses of 14 banned fixed dose combination
On June 2, 2023, the Ministry of Health and Family Welfare through a gazetted notification ("FDCs Notification") prohibited manufacturing, sale and distribution of 14 banned fixed dose combination drugs ("Banned FDCs") owing to their harmful effects on human lives.6 In furtherance of the FDCs Notification, the Gujarat Food and Drug Control Administration ("GFDCA") has cancelled 394 product licenses issued to the companies engaged in manufacturing of the Banned FDCs in the state of Gujarat. The Banned FDCs include over the counter drugs such as ammonium chloride, bromhexine, dextromethorphan, chlorpheniramine, used for medication of cough, fever, and infections. Further, the GFDCA has also sent message alerts to manufacturers, distributors, and retailers requiring them to immediately stop the manufacturing and sale of the Banned FDCs.7
Delhi High Court directs GOI to file reply in relation to the petition filed against the FDCs Notification
In an order dated July 17, 2023,8 the Delhi High Court has directed the GOI to submit its response in a writ petition filed by Seagull Laboratories (India) Private Limited.9 The petition was filed to revoke the FDCs Notification which banned the manufacturing, sale, and use of the Banned FDCs. The petitioner has claimed that the FDCs Notification only states that the Banned FDCs may cause health risks to human beings without specifying the reasons, extent, or nature of such risks. In this regard, the Delhi High Court, in an earlier order dated July 3, 2023, had granted relief to the petitioner, and had passed directions that the Banned FDCs which were already in the distribution channel will not be withdrawn, and that no coercive steps will be taken against the petitioner.
Guidelines formulated to restrict changing of manufacturers by marketing companies
Recently, there have been growing instances of pharmaceutical marketing companies replacing their manufacturers without informing the National Pharmaceuticals Pricing Authority ("NPPA"). With an aim to decrease such instances, the NPPA has introduced guidelines to lay down a case specific assessment process in relation to filing and processing of applications from marketing companies seeking a change of their manufacturer for formulations whose retail prices have already been notified.
As per the guidelines, NPPA, going forward, will permit a marketing company to change its manufacturer only upon the occurrence of any of the following events: (a) cancellation or seizure of license of the manufacturing company; (b) natural calamity or civil riots leading to destruction of plant of the manufacturing company; (c) dissolution or winding up of the manufacturing company; (d) closure of the concerned business unit by the manufacturing company; or (e) any other circumstances proved to be beyond the control of the manufacturer or the marketing company. The responsibility of proving occurrence of any of the above events will be that of the applicant marketing company.10
Central Drugs Standard Control Organisation to undertake daily updation of cough syrup samples to enable time-bound testing
In order to facilitate time-bound testing and publications of reports, the Central Drugs Standard Control Organisation ("CDSCO"), through a circular dated June 13, 2023,11 has notified that it will publish on its website, on a daily basis, the number of batches of cough syrup samples received and tested by central and state drug laboratories prior to their export. The new mechanism would ensure release of test reports in a time-bound manner. The CDSCO has adopted the new mechanism in light of the reports of the World Health Organisation alleging that the consumption of certain cough syrups imported from India has resulted in death and adverse reactions in people in Gambia and Uzbekistan.12
India to adopt Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme to strengthen the quality of its medical products
India is set to adopt the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme13 with an aim to strengthen the quality and standard of medical products. This scheme allows its member nations to exchange knowledge, share best manufacturing practices, and jointly improve the safety and quality of medical products. Once this scheme is adopted by India, the Indian medical industries shall endeavour to adopt international standards relating to: (a) good manufacturing practices; and (b) quality control, in order to ensure consistency with other member nations such as Australia, Belgium, and Canada.14
United States Food and Drug Administration accepts application filed by Dr. Reddy's Laboratories for rituximab's biosimilar product
The United States Food and Drug Administration has accepted for substantive review the biologics license application filed by Dr. Reddy's Laboratories for its proposed rituximab's biosimilar product 'DRL_XI' ("DRLXI"). Rituximab is an antibody primarily used to treat autoimmune diseases and certain types of cancer (including non-Hodgkin's lymphoma and chronic lymphocytic leukaemia in adult patients). DRLXI has also been accepted for review by the European Medicines Agency and the (United Kingdom) Medicines and Healthcare Products Regulatory Agency. In India, DRLXI has been approved for marketing.15
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Footnotes
1. The draft amendment was issued on August 28, 2018, and is yet to come into effect. It can be accessed at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTkzOQ==
2. Dr. Zaheer Ahmed v. Union of India (W.P.(C) 11711/2018 & CM APPL. 45307/2018).
4. http://www.pharmabiz.com/NewsDetails.aspx?aid=159505&sid=1
5. https://www.mohfw.gov.in/pdf/Doorstepdelivery26B.pdf
6. The notification can be accessed at: https://xln.gujarat.gov.in/DOCS/Prohibition_of_14_FDC.PDF
7. http://www.pharmabiz.com/NewsDetails.aspx?aid=159657&sid=1
8. Seagull Laboratories I Private Limited v. the Union of India (W.P.(C) 8460 of 2023).
9. The Delhi High Court through its earlier orders dated June 14, 2023, and July 3, 2023, had also directed the GOI to submit its responses to the above petition
10. Guidelines were adopted at the 113th meeting of the NPPA. The minutes of the meeting containing the guidelines can be accessed at: https://www.nppaindia.nic.in/wp-content/uploads/2023/06/113th-Authority-Meeting.pdf.
12. http://www.pharmabiz.com/NewsDetails.aspx?aid=159733&sid=1
13. https://picscheme.org/docview/2147
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