Dentons US LLP
07/02/2024 | News release | Distributed by Public on 07/02/2024 03:04
Lifesciences and Healthcare Newsletter - May 2024
July 2, 2024
Stay updated with the latest developments in the life sciences and healthcare sectors with our May 2024 newsletter. The Central Drugs Standard Control Organization (CDSCO) and the Department of Pharmaceuticals have issued significant updates affecting India's healthcare and pharmaceutical sectors, including new regulations for medical devices and updated pharmacovigilance guidelines. Additionally, the Department of Pharmaceuticals mandated self-declarations under the UCPMP for FY 2024-2025. The Central Council for Research in Ayurvedic Sciences launched PRAGATI-2024 to boost collaboration in Ayurveda. Notably, Mr. Pradnesh Warke represented Dentons Link Legal at the BIO International Convention 2024, highlighting India's engagement in global biotech and pharma.
Industry Updates
1. CDSCO issues regulation of all Class C and Class D medical devices under the Licensing regime
On May 16, 2024, the Central Drugs Standard Control Organization ("CDSCO") issued a circular that provides an extended grace period for importing unregistered Class C and D medical devices whose applications are already under CDSCO review. This decision comes in response to concerns raised by industry associations and stakeholders about maintaining business continuity during this transitional phase.
The Ministry of Health & Family Welfare ("MoHFW") has decided to allow existing importers/ manufacturers who are already importing/ manufacturing any of the Class C and D Medical Devices, that have submitted their licensing applications on or before September 30, 2023, to the Central Licensing authority for grant of import/manufacturing license in respect of the said devices(s) under the provisions of Medical Devices Rules, 2017, the said application shall be deemed valid and the importer/manufacturer can continue importing or manufacturing Class C or D devices up to 3 months from the date of issue of the order or till the time the Central Licensing Authority, takes a decision on the said application, whichever is earlier.
2. CDSCO issues circular for Retention of License or Certificates under Medical Device Rules, 2017 (MDR 2017)
Under the MDR 2017, license for manufacturing or import of Medical Devices and Registration Certificate for QMS Audit by Notified Body as well as for Medical Devices Testing Laboratory is issued in perpetuity, provided that a payment of requisite fee is deposited in stipulated timeline under MDR 2017 or unless it is suspended or cancelled by the Licensing Authority.
Further, the endorsements to the licenses/ certificates issued will also be valid till the validity of its base license/ certificate. If the requisite fee is not deposited by the applicant as per stipulated timeline, the license/certificate shall be deemed to have been cancelled.
In view of the above, the CDSCO on May 15, 2024, has issued a critical reminder to all stakeholders to ensure payment of the requisite fees well before the stipulated timeline under the MDR 2017, to avoid the cancellation of their approvals and submit the application to the Licensing Authority in order to maintain continuity of the product in the market.
3. CDSCO releases Guidance for Industry Version 1.2 Biologicals
On May 15, 2024, the CDSCO published the Guidance for Industry for Biologicals, marking a significant update after a 16-year gap since the previous version. The previous version 1.1 published in 2008 was prepared in line with the international guidelines and in accordance with Drugs and Cosmetics Rules, 1945, and the Drugs and Cosmetics Act, 1940. However, the new guidance is updated to align with the New Drugs and Clinical Trials Rules, 2019 and the SUGAM application process after consultation with the stakeholders and after considering the public suggestions/comments/objections.
4. CDSCO prepares draft Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines
On May 29, 2024, the CDSCO prepared a draft Guidance for Industry on Pharmacovigilance requirements for Human Vaccines, version 2.0 in consultation with the Adverse Event Following Immunization (AEFI) Secretariate and IPC-PVPI to align with New Drugs and Clinical Trials Rules, 2019.
The CDSCO has decided to solicit suggestions/ comments/ objections from the stakeholders with regards to the draft guidance document, the same may be forwarded with valid justification within 15 days from the date of issuance of the notice by email at - [email protected].
5. Testing and evaluation of Medical Devices/ In vitro Diagnostics by Medical Devices Testing Laboratories
In order to ensure the quality, safety and performance of Medical Devices (MD)/ In vitro diagnostics (IVDs), the MoHFW has granted registration of Laboratory for carrying out Test or Evaluation of a Medical Device on behalf of a manufacturer, under Chapter X of the MDR 2017 to strengthen the testing facility in the country. Further, consequent to the implementation of the MDR 2017, the Drug Rules, 1945 are no longer applicable for MDs/IVDs and the product standards of Medical Devices are prescribed under Rule 7 of the MDR 2017 are mandatory.
In light of the above, the CDSCO vide circular dated May 29, 2024, has observed that the testing of Medical Devices which have BIS standards available, are not being carried out in accordance with the same. Therefore, the CDSCO has mandated that samples of medical devices shall comply to the BIS standards for its quality and performance and accordingly the medical devices shall be tested with respect to the requirements as prescribed in the BIS standards. If no BIS standard is available, then only other standards as mentioned in Rule 7 of the MDR 2017 may be applied.
6. Department of Pharmaceuticals mandates all Pharmaceutical Associations to file self-declaration under the Uniform Code for Pharmaceutical Marketing Practices for FY-2024 - 2025
On May 28, 2024, the Department of Pharmaceuticals ("DoP") published the self- declaration applicable for FY 2024-2025 under the Uniform Code for Pharmaceutical Marketing Practices ("UCPMP") 2024, in the prescribed form and should be submitted by June 30, 2024, in accordance with the procedure given in the UCPMP 2024.
7. Department of Pharmaceuticals mandates Medical Device Associations to file self-declaration under UCPMP by June 30, 2024
On May 30, the DoP extended the time limit for submitting the Self-Declaration under the UCPMP 2024 to June 30, 2024, for Medical Device Associations.
General Updates
1. Central Council for Research in Ayurvedic Sciences Launches PRAGAT 2024, an initiative to shape the future of Ayurveda Industry
On May 28, 2024, the Central Council for Research in Ayurvedic Sciences ("CCRAS"), under the Ministry of Ayush, hosted "PRAGATI-2024" at the India Habitat Centre in New Delhi. This interactive meeting was aimed at exploring research opportunities and foster collaboration between CCRAS and the Ayurveda drug industry. High-profile attendees included Vaidya Rajesh Kotecha, Secretary of Ayush Ministry, who delivered a keynote speech, along with other ministry officials. Prof. Vaidya Rabinarayan Acharya, Director General of CCRAS, lead the meeting, emphasizing the need for quality, safe, and effective Ayurveda products. The event's primary goals were to utilize CCRAS's research outcomes, establish collaborative networks, identify industrial partners, explore capacity-building opportunities, and assist Ayurveda professionals in starting businesses. Representatives from 35 pharmaceutical companies, including CEOs from renowned firms like Himalaya, Emami, and Dabur participated.
2. 77th World Health Assembly approves amendments to International Health Regulations 2005
In a significant global health security milestone, the 77th World Health Assembly has unanimously approved a package of amendments to the International Health Regulations (IHR 2005). These changes, based on 300 proposals from member countries post-COVID-19, aim to enhance nations' preparedness and response to international health emergencies. Key provisions include ensuring equitable access to health products and mobilizing financial support for developing countries. The achievement comes after nearly two years of complex negotiations by two separate groups. A breakthrough occurred on May 28, 2024, when Shri Apurva Chandra proposed a unified drafting group, co-chaired by members from both negotiating bodies, to tackle critical issues. This proposal, unanimously accepted, led to the successful finalization of the IHR amendments. India played a pivotal role in shaping this instrument, which emphasizes equity in global health emergency responses.
3. Indian hosted side event on digital health at the 77th World Health Assembly attended by Quad countries and delegates from over 100 nations
During the 77th World Health Assembly held at Geneva, India showcased its digital health advancements at a side event attended by Quad countries and delegates from over 100 nations. The focus was on leveraging Digital Public Infrastructure to address health determinants. Union Health Secretary Shri Apurva Chandra highlighted India's success in implementing large-scale digital systems like Aadhaar, UPI, and Co-WIN. He announced Co-WIN's transformation into UWIN for comprehensive immunization tracking. Under the Ayushman Bharat Digital Mission (ABDM), India has generated over 618 million health IDs, reflecting its commitment to digital healthcare.
Key Judgements
Noteworthy judgements in the realm of Healthcare and Lifesciences to increase awareness and knowledge.
1. Indian Medical Association & Anr vs. Union of India and Ors. - WP (Civil) No. 645/2022 (in the Supreme Court of India)
Yoga guru Ramdev and his aide Balkrishna face a contempt case in the Supreme Court for Patanjali Ayurved's misleading advertisements and unsubstantiated Covid cure claims. Despite acknowledging their contributions to yoga, the court, led by Justices Kohli and Amanullah, remains skeptical of their sincerity, having rejected two previous apologies that were sent to the media.
The case originates from Patanjali's 2021 claim that Coronil, an Ayurvedic drug by Patanjali, was the "first evidence-based medicine for COVID-19," a statement the Indian Medical Association (IMA) called a "blatant lie." Further inflaming the situation, Ramdev described allopathy as a "stupid and bankrupt science," and Patanjali ran ads claiming their drugs cured various ailments.
The Supreme Court has been increasingly stern, warning Patanjali against false claims in November 2023 and threatening heavy fines. Despite assurances from Patanjali's counsel, misleading ads continued, prompting an anonymous letter to the Chief Justice. The court reprimanded the company for taking the country "for a ride" and criticized the government's inaction.
In response to the Supreme Court's rebuke over its failure to act against Patanjali Ayurved Ltd and Divya Pharmacy for misleading advertisements, the Uttarakhand State Licensing Authority ("USLA") has taken significant action. On April 15, it suspended licenses for 14 products manufactured by these companies, citing repeated violations under the Drugs and Cosmetics Rules, 1945.
The Joint Director, Mithilesh Kumar, filed an affidavit apologizing for any non-compliance with court orders. Additionally, on April 16, a criminal complaint was filed against Ramdev, Acharya Balkrishna, and their companies under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. On April 23, the USLA issued directives to all Ayurvedic/Unani medicine factories in Uttarakhand, prohibiting them from making claims like "Approved/Certified by the Ministry of AYUSH" and mandating compliance with various laws governing advertising and labelling.
2. Jacob Vadakkanchery v. Union of India - 2024 SCC OnLine Del 3686
The petition was filed to make it mandatory for all medical professionals practicing in the country to specify, to the patient, all kinds of possible risks as well as side effects associated with a drug or a pharmaceutical product that has been prescribed in the form of an additional slip in the regional language. The petitioner argued that prescription medications can significantly harm patients and that patients have the right to make informed choices. They contended that prescribing without specifying side effects doesn't constitute valid consent, urging a shift in responsibility from manufacturers and pharmacists to doctors, as consumers often overlook package inserts.
The respondents countered that this requirement was impractical, given doctors' heavy workloads, and would hinder rather than facilitate medical advice. Furthermore, they argued that some side effects of Schedule D drugs become evident only after widespread use and accumulated data. Placing the obligation on doctors to inform patients could expose them to negligence allegations, even when a side effect's possibility was uncertain at the time of prescription.
The petitioner admitted that there existed legislative safeguards with respect to informing the patient about the possible side effects of the prescribed drugs. Further, the Court noted that Schedule D(II) of the Drugs and Cosmetics Act, 1945 puts an obligation on the manufacturer or his agent to provide a package insert which shall duly disclose the side effects of the drugs to the consumer. Further, Regulation 9.11 of Chapter IV of the Pharmacy Practice Regulations, 2015 imposed a duty upon the registered pharmacist to apprise the patient or his carer about the possible side effects.
The Court noted that the petitioner does not dispute the sufficiency of the information supplied by the manufacturer through the insert. However, the petitioner contended that if the insert is provided by the doctor along with the prescription, it would be presumed that the patient would be able to make an informed choice with valid consent. The Court reiterated the observations made in Ashwani Kumar v. Union of India (2020) 13 SCC 585 to state that it is outside the power of judicial review to issue directions to the legislature to enact a law in a particular manner.
The Court, while dismissing the PIL, stated that since the legislature had elected to impose this duty on the manufacturer and pharmacist, no ground was found for issuing any direction.
Events
1. BIO International Convention 2024 held in San Diego was attended by Mr. Pradnesh Warke
BIO International Convention 2024 - the largest pharmaceutical convention globally, took place from 3rd to 6th June in San Diego, California. The Convention attracted more than 15,000 biotechnology and pharmaceutical professional leaders.
Our Lifesciences and Healthcare Partner, Mr. Pradnesh Warke attended this convention to represent Dentons Link Legal. He was accompanied by partners from various offices of Dentons Global Lifesciences and Healthcare group.
Contributors to the newsletter:
- Nusrat Hassan, Managing Partner
- Pradnesh Warke, Partner
- Sidhartha Srivastava
- Tanay Jha, Associate
- Ravi Shekhar, Associate