INTRODUCTION
Martin Luther King Junior famously said, "Of all the forms of inequality, injustice in health is the most shocking and inhumane." Echoing this assertion, in the recently concluded parliamentary session there was a significant emphasis on addressing healthcare inequality and fostering innovation within the healthcare industry. Notably, several important bills and policies were passed, highlighting the government's commitment to focus on incentivizing research and innovation in this sector. These recent developments have set the healthcare and pharmaceutical industry on a compelling and promising trajectory that the stakeholders must keep a tab on.
This edition of 'Checking the Pulse' delves into crucial updates spanning from August to September 2023 in the healthcare and pharma sector and briefly talks about major deals which drew attention from the industry.
RECENT LEGAL & REGULATORY DEVELOPMENTS
CDSCO approves three private laboratories for testing cough syrups prior to their export
The Central Drugs Standard Control Organisation, pursuant to a circular dated September 13, 2023, has granted approval to three private testing laboratories, accredited by the National Accreditation Board for Testing and Calibration Laboratories, to test cough syrups which are to be exported by Indian manufacturers. The three private laboratories which have been granted the approval are Bee Pharmo Labs Private Limited, Oasis Test House, and Shriram Institute for Industrial Research. Prior to the issuance of the circular, only government laboratories were permitted to test cough syrups for exports.1
Delhi High Court dismisses applications filed by Cadila and Hetero Drugs in the suit of bio similarity filed by Roche
In 2016, Hoffman La Roche, a Swiss drug manufacturer, had filed a suit against Cadila Healthcare Limited and Hetero Drugs Limited, alleging that the drugs of Cadila and Hetero were approved for manufacturing and distribution, despite being non-compliant with the Drugs and Cosmetics Act, 1940 ("D&C Act") and Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorisation in India, 2012. Roche had alleged that: (a) the mandatory requirement of conducting human trials prior to grant of approval for manufacturing and distribution was not followed; (b) there were irregularities in the conduct of pre-clinical trials; and (c) certain phases of clinical trials were skipped. Cadila and Hetero are claiming bio-similarity with Roche's drugs Trastuzumab and Bevacizumab (anti-cancer medications) respectively ("Drugs"), to which Roche opposes.
In recent applications filed by Cadila and Hetero, they had pleaded that the suit filed by Roche shows no cause of action because Roche does not enjoy any intellectual property rights over the Drugs. The Delhi High Court, in a judgment delivered on September 11, 20232, rejected the applications and allowed Roche to proceed with its suit against Cadila and Hetero.
Delhi High Court upholds notification classifying all medical devices as drugs
The Delhi High Court, in its judgment dated September 1, 20233, has held that the notification issued by the Ministry of Health and Family Welfare ("Health Ministry"), bringing all medical devices within the definition of 'drug' under the D&C Act, is constitutionally valid. The Surgical Manufacturers and Traders Association ("Petitioner") had challenged the notification issued on February 11, 2020, which brought all medical devices within the definition of 'drug' under the D&C Act.
The Petitioner argued that the Health Ministry was not empowered to include all medical devices under the definition of 'drug' in an omnibus fashion and could only notify specific devices as 'drugs'. The Petitioner had argued that the notification: (a) was released without conducting stakeholder consultations; (b) shifts focus from regulating only critical medical devices, to also regulating non-critical, non-invasive devices meant for transient use; and (c) puts micro, small and medium-scale manufacturers, importers, and traders in a disadvantageous position. In response to the Petitioner's contentions, the Health Ministry argued that the notification intends to enhance patient safety.
The Delhi High Court held that no express prohibition or limitation exists in the D&C Act concerning the Health Ministry's power to bring all medical devices under the ambit of the D&C Act, and that the Health Ministry did so after extensive deliberations and expert advice given by the Drugs Technical Advisory Board. The Delhi High Court also held that classifying all medical devices as 'drugs' was a policy decision that the judiciary cannot interfere with under its power of judicial review.
National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 held in abeyance
Pursuant to a notification dated August 23, 2023, the National Medical Commission ("NMC") has put the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 20234 ("NMC Regulations") in abeyance until further notification.5 The NMC Regulations had prescribed detailed duties and responsibilities of registered medical professionals, including guidelines on prescription of drugs with generic, non-proprietary, or pharmacological names; taking informed consent from patients; telemedicine; and prohibition on participation in third-party educational activities involving direct or indirect sponsorships from pharmaceutical companies. Until the NMC Regulations are notified, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002,6 which were notified by the erstwhile Indian Medical Council, will govern registered medical professionals.
While the NMC Regulations have been put in abeyance, a public interest litigation petition has been filed in the Supreme Court, seeking disciplinary action against medical practitioners prescribing branded drugs to patients and requesting the Supreme Court to direct the NMC to fix maximum retail prices for generic drugs.7 The Supreme Court has issued a notice to the NMC in this regard.
Draft Patents (Amendment) Rules, 2023 propose fee for filing pre-grant oppositions and extend timelines to demonstrate working of patented drugs
On August 22, 2023, the Department for Promotion of Industry and Internal Trade released the Draft Patents (Amendment) Rules, 20238 ("Draft Patents Rules"). The Draft Patents Rules specify the following: (a) in case of opposition to grant of a patent, the Patents Controller will first determine the maintainability of such opposition; and (b) companies will be required to file a statement informing the extent to which their patented invention has worked on a commercial scale in India after every three years, starting from the financial year commencing immediately after the financial year in which the patent was granted, replacing the previous provision of one year. While the Patents Rules, 20039, do not levy any fee for filing pre-grant oppositions, the Draft Patents Rules levy a fee for such filings. Various patient advocacy groups have opposed the Draft Patents Rules stating that they could impair filing of representations by and on behalf of patients, and affect access to affordable healthcare.10
Scheme for Promotion of Research and Innovation in Pharma MedTech Sector notified by Department of Pharmaceuticals
On August 16, 2023, the Department of Pharmaceuticals ("DOP"), Ministry of Chemicals and Fertilisers, notified the Scheme for Promotion of Research and Innovation in Pharma MedTech Sector ("PRIP Scheme").11 The PRIP Scheme intends to increase research and development ("R&D") expenditure in the Pharma MedTech sector and re-position India from a manufacturer of generic drugs to that of patented drugs. It aims to concentrate on emerging high-value product categories in the pharmaceutical industry, including biopharmaceuticals, complex generic drugs, patented drugs, or drugs nearing patent expiry, and cell based or gene therapy drugs. The initial five-year budget of the PRIP Scheme is INR 5,000 crores.
The PRIP Scheme proposes to: (a) establish Centres of Excellence at the seven National Institutes of Pharmaceutical Education and Research; and (b) incentivise the Pharma MedTech industry to undertake R&D in six priority areas (including complex generics and biosimilars, precision medicine, medical devices, orphan drugs, and drug development for antimicrobial resistance) by providing financial assistance.
National Policy on Research and Development and Innovation in the Pharma MedTech sector notified by DOP
On August 16, 2023, the DOP notified12 the National Policy on R&D and Innovation in the Pharma MedTech Sector ("R&D Policy"). The R&D Policy aims to: (a) enable rapid drug discovery, and development in the medical devices industry by streamlining regulatory processes; (b) incentivise private investment in R&D; and (c) expedite the development and availability of innovative drugs and medical devices. To achieve the abovementioned aims, the R&D Policy has set out the following focus areas:
- creation of a single end-to-end digital portal between the
regulators and the manufacturers;
- incentivising investment in innovation through various fiscal
and non-fiscal incentives such as blended finance and Biotech
Innovation Fund; and
- providing an enabling ecosystem for research and innovation through industry-academia linkages.
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Footnotes
2. F Hoffman-La Roche Limited and others v. Drugs Controller General of India and Others (CS (Comm) 540/2016.
3. Surgical Manufacturers and Traders Association v. Union of India (Writ Petition (Civil) 43497 of 2019, 50395 of 2019, 29106 of 2020, 9412 of 2021 and 15630 of 2021).
5. https://www.nmc.org.in/MCIRest/open/getDocument?path=/Documents/ Public/Portal/LatestNews/248297.pdf
6. https://www.nmc.org.in/wp-content/uploads/2017/10/Ethics-Regulations-2002.pdf
7. Kishan Chand Jain v Ethics and Medical Registration Board (Writ Petition (Civil) No. 794 of 2023). A copy of the latest order can be accessed at: https://main.sci.gov.in/supremecourt/2023/25176/25176_2023_1_7_46241_ Order_18-Aug-2023.pdf
8. https://dpiit.gov.in/sites/default/files/draft_ PatentRules_2023_25August2023_1.pdf
9. https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Indian_Patent_ Rules_2003__1_.pdf
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