Lifesciences and Healthcare Newsletter June- 2024

Welcome to the June 2024 edition of our Lifesciences and Healthcare Newsletter. This issue covers recent updates and regulatory changes in India's lifesciences and healthcare sectors. We discuss the clarification to the self-declaration under the UCPMP Code, compliance with which is required from pharmaceutical and medical device companies. The National Pharmaceutical Pricing Authority has set price ceilings for 54 drug formulations, and the CDSCO has flagged 52 drugs for quality issues. In investment news, Corona Remedies acquired the Myoril brand from Sanofi India for INR 234 Crores. Med-tech updates include draft rules for breath analyzers, while health-tech highlights the National Action Plan on Antimicrobial Resistance and new guidelines for inter-departmental hospital referrals. The MIB revised self-declaration requirements for food and health product ads, and the FSSAI mandates the removal of '100% Fruit Juices' claims from labels. The MoHFW launched new healthcare initiatives, including virtual NQAS assessments and a spot food license initiative. Concerns over new criminal laws affecting medical negligence have been raised, and the Supreme Court upheld NPPA's demand for recovery against Sun Pharma for overcharging. Stay informed with our detailed articles and updates on these developments.

Article

Lifesciences and Healthcare Update: Clarification to the self-declaration required under the UCPMP Code

The Uniform Code for Pharmaceutical Marketing Practices, 2024 ("UCPMP Code") was promulgated on March 12, 2024, by the Department of Pharmaceuticals ("DoP") which seeks compliance with its tenets from all pharmaceutical and medical device companies in India.

Read more here.

Sector General Updates

Pharmaceutical

Legal and Regulatory

National Pharmaceutical Pricing Authority fixes price of 54 drug formulations

The National Pharmaceutical Pricing Authority ("NPPA") has fixed a price ceiling for 54 drugs as per an order dated 14 June 2024. The order includes drugs from a range of manufacturers including Intas Pharmaceutical Ltd., Mankind Pharma Ltd., Lupin Ltd., and others.

In accordance with the Drugs (Prices Control) Order, 2013 ("DPCO"), the manufacturers are required to furnish a price list to the NPPA in Form V.

Read More here.

Government Initiatives

52 drugs fail the Central Drugs Standard Control Organization quality check

The Central Drugs Standard Control Organization ("CDSCO") has flagged that 52 drug samples, including popular medications like paracetamol, pantoprazole, and various antibiotics used for bacterial infections, as not meeting standard quality requirements. The drug samples failed the quality tests conducted by CDSCO, as per a drug alert issued on 20 June 2024. The samples were collected from multiple locations including Jaipur, Hyderabad, Waghodia, Vadodara in Gujarat, Andhra Pradesh, and Indore.

State drug regulators have initiated notices to the concerned pharmaceutical companies, signaling plans for a market recall of the failed samples. Last year, approximately 120 drug samples manufactured in Himachal Pradesh had also failed quality parameters.

Read more here.

Investment News

Corona Remedies acquires Myoril brand from Sanofi India for INR 234 Crores

Corona Remedies Private Limited has acquired the brand Myoril and Myoril Plus from Sanofi India Limited. The acquisition costed the Gujarat-based firm INR 234 crores. Myoril is used to treat muscular pain and has composition of Thiocolchicoside and Ketoprofen + Thiocolchicoside in Myoril Plus.

As per media reports, the acquisition is effective from 28 June 2024. Corona Remedies is backed by ChrysCapital which has 30% stake in the company.

Read More here.

Med-Tech and Medical Device

Legal and Regulatory

Central Government released draft rules for specifications of breath analyzing devices

The Legal Metrology Division under the Ministry of Consumer Affairs, Food and Public Distribution has released a draft rule to amend the Legal Metrology (General) Rules, 2011 to include mandatory verification and stamping of 'evidential breath analyzer'. The draft rules define 'evidential breath analyzer' as "quantitative instruments that render a measurement result of alcohol concentration in exhaled human breath for the purpose of establishing compliance, for fighting against alcohol abuse and/or for the advancement of public safety."

The draft rules specify various technical requirements like displaying only the final measurement result, including a printer to record results, ensuring the device does not operate without paper, etc.

The draft rules are open for public comment till 26 July 2024.

Read more here.

Heath-Tech, Hospitals and Healthcare Institutions

Government Initiative

The NMC has released a National Action Plan on Antimicrobial Resistance Module for Prescribers 2024

The National Medical Commission (NMC) has released the National Action Plan on Antimicrobial Resistance (NAP-AMR) Module for Prescribers, 2024. The module has been framed in accordance with the World Health Organization's guidelines on the same issue. The module lays down six key focus areas with elaborate interventions, activities, and key outputs along with responsible agencies and expected timelines.

The six focus areas stated in the module are: (i) Improving awareness and understanding of antimicrobial resistance through effective communication, education, and training. (ii) Strengthening knowledge and evidence through surveillance. (iii) Reducing the incidence of infection through effective infection prevention and control. (iv) Optimizing the use of antimicrobial agents in health, animals, and food. (v) Promoting investments for antimicrobial resistance activities, research, and innovations. (vi) Strengthening India's leadership on antimicrobial resistance.

Read more here.

Guidelines for inter-departmental referral (within hospitals)

The Director General of Health Services has issued a guideline to all medical colleges and hospital for inter-departmental referral of patients within the hospital. The guidelines are not mandatory in nature and provide a framework for hospitals to develop their own standard operating procedures to suit their internal setup.

The guidelines include general principles for referral, do's and don'ts for inter-departmental referrals, circumstances like referral denial or rejection, patient non-attendance, discharge planning, referral for transfer from one department to another, patient death, etc.

Read more here.

Health Advertising and Marketing Laws

Legal and Regulatory

Ministry of Information and Broadcasting issues advisory on annual self-declaration for advertising of food and health products

The Ministry of Information and Broadcasting ("MIB") has issued a revised advisory to clarify that the advertisers / advertising agencies issuing advertisements for products and services related to food and health sectors are required to upload an annual self-declaration certificate on either the Broadcast Sewa Portal or the portal of the Press Council of India.

Earlier, as per the previous advisories of the MIB, every advertiser or advertising agency was required to file a self-declaration for every advertisement that it planned to air or print on any medium.

Read more here.

Fitness and Wellness

Legal and Regulatory

FSSAI directs FBOs to remove claim of 100% Fruit Juices from the label and advertisement of fruit juices

The Food Safety and Standards Authority of India (FSSAI) has mandated that all food business operators (FBOs) cease using the claim '100% fruit juice' on labels and advertisements for reconstituted fruit juices. This order is effective immediately, and FBOs are instructed to deplete their stock of pre-printed packaging materials by the 01 September 2024.

Furthermore, the directive specifies that juices produced from fruit concentrates must be labeled as 'reconstituted'. Additionally, if the quantity of added nutritive sweeteners exceeds 15 grams per kilogram, the product must be identified as 'sweetened juice'.

Read more here.

The MoHFW launches virtual NQAS assessment for Ayushman Arogya Mandirs, dashboard for IPHS and spot food license initiative for food vendors

The Ministry of Health and Family Welfare ("MoHFW") has launched three initiatives to improve the quality of healthcare services and promoting the ease of doing business in India.

The three initiatives are: (i) a virtual National Quality Assurance Standards (NQAS) assessment for Ayushman Arogya Mandirs; (ii) a dashboard which will help national, state and district health institutions and facilities in quickly monitoring compliance with respect to Indian Public Health Standards; and (iii) a spot food license and registration initiative for food vendors.

Read more here.

Government initiatives

MoHFW issues draft guidelines for withdrawal of life support in terminally ill patients

The MoHFW has issued a draft guideline for withdrawal of life sustaining treatment in terminally ill patients. The Guidelines provide for scenario where life sustaining treatments maybe withdrawn or withheld, while also laying down the principles that must be upheld while foregoing life support. The Guidelines is in tune with the Supreme Court of India's order in Misc. Application No. 1699/2019 in WP (Civil) No. 215/2005 dated 24 January 2023 wherein the Court, while discussing a person's right to live with dignity and right to die with dignity, detailed the procedure for executing a living will which the Court termed as 'Advanced Medical Directive'.

Read more here.

MoHFW issues guidelines for ethical use of leftover de-identified and anonymous samples for commercial purpose

MoHFW has issued a guideline to address the ethical use of leftover, irreversibly de-identified samples, or pooled samples, that are non-identifiable collected for clinical care (non-research) for development of future products or technologies for commercial purposes. The samples include organs, parts of organs, cells, tissues, cell products such as blood, blood products (even positive for hepatitis B / hepatitis C / human immunodeficiency virus / syphilis and expired blood), urine, saliva, DNA/RNA, hair, nail clippings, or any other cells, body fluids etc.

The Guideline further states that the source for these specimens may be patients, autopsy specimens, abandoned wastes, tissue banks, IVF clinics and organ donation centres among others. The Guidelines is not applicable for use of leftover 'research' samples, since their secondary use must be aligned with the original informed consent given by the research participant.

Read more here.

Medical Negligence

Legal and Regulatory

Doctors express concern over the new Criminal Laws as it saddles doctors with criminal prosecution for medical negligence

The three new criminal laws passed by the Parliament were bought into effect from 01 July 2024. One of the new criminal laws, the Bhartiya Nyaya Sanhita ("BNS") replaced the existing Indian Penal Code ("IPC") which has sparked outrage amongst the medical community.

Section 106 of BNS sets out that death from any rash or negligent act done by a registered medical practitioner while performing a medical procedure shall be punished by imprisonment up to two years and shall also be liable to fine.

Earlier under IPC, medical practitioners were implicated under Section 304 A of IPC which was general in nature and did not specifically include medical professionals. Section 304A set out that "whoever causes death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both".

The specific insertion to bring medical practitioners within the ambit of BNS and further the use of the word "and" which implies mandatory jail term for medical practitioners in cases of medical negligence has sparked outrage among the medical community. In protest of the new laws, the Indian Medical Association has launched a month-long campaign across states urging the Central Government to amend the BNS.

Read More here.

Litigation and Disputes - Case Laws

M/s Sun Pharmaceutical Industries Ltd vs Union of India & Ors, (Civil Appeal No. 7209 of 2019)

The Supreme Court recently passed a judgment emphasizing the broad objective of the Drugs (Price Control) Order, 1995 ("DPCO, 1995"), which was to regulate the prices of medicines for the benefit of the general public.

The bench comprising of Justice Sanjay Kumar and Justice Augustine George Masih of the Hon'ble Supreme Court upheld the demand for recovery issued by the NPPA against M/s. Sun Pharmaceutical Industries Ltd ("Sun Pharma") for selling Cloxacillin-based drug formulation called Roscilox above the ceiling price specified under DPCO, 1995.

The NPPA had issued demand notices to Sun Pharma on 8th February 2005 and 13th June 2005, seeking payment of Rs. 4,65,08,333 (inclusive of principal and interest) for overcharging of Roscilox between April 1996 and July 2003.

Aggrieved by the said demand notice, Sun Pharma filed a Writ Petition challenging the demand notices which was dismissed by a single judge of the Delhi High Court. Thereafter, Sun Pharma filed an appeal before the division bench of the Delhi High Court. The division bench of the Delhi High Court dismissed the appeal and upheld the decision of the single judge of the Delhi High Court.

Aggrieved by the decision of the Division Bench of the High Court, Sun Pharma approached the Supreme Court.

The core of the dispute was whether NPPA's demand notices, issued under Paragraph 13 of the DPCO, 1995 were justified. This provision empowers the government to recover excess amounts from manufacturers, importers, or distributors who breach the price controls specified in DPCO, 1995.

Sun Pharma argued that it should not be subject to Paragraph 13 of the DPCO, 1995 since it was merely a dealer and not a manufacturer, importer, or primary distributor of Roscilox. However, the Supreme Court observed that Sun Pharma's direct procurement of the drug from manufacturer Oscar Laboratories Pvt. Ltd demonstrated involvement beyond a mere dealer's role.

Despite attempts to argue corporate separation between Oscar Laboratories Pvt. Ltd and its own group companies, the Supreme Court affirmed Sun Pharma's liability under Paragraph 13 of the DPCO, 1995.

In conclusion, Supreme Court upheld the Delhi High Court's decision to dismiss Sun Pharma's Writ Petition challenging the demand notices.

Read More here.

Contributors to the newsletter:

• Nusrat Hassan, Managing Partner
• Pradnesh Warke, Partner
• Sidhartha Srivastava
• Tanay Jha, Associate
• Ravi Shekhar, Associate

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