Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Draft Guidance on Vaccine Approval and Quality Monitoring at port of Import published by Central Drug Regulator for Public Commect
The Central Government has recently published a draft of guidance on (1) regulatory framework for conducting vaccine related clinical trials, marketing approval, manufacture, import/ export and post marketing assessment and (2) Risk Based Approach for monitoring quality of imported drugs, medical devices and IVDs at customs ports. Public Comment is sought on these above Guidance Notes, within 30 days of publication i.e. by 10th May 2024.
Source: bit.ly/3xIoiIv
Source: bit.ly/4cVOpvL

Merchants Association Request Central Government Intervention to Stabilize trade of Medicines and Medical Devices with Africa
The Federation of Pharmaceutical and Allied Products Merchant Exporters, an industry association of small and medium sized importers and exporters, has advocated for fiscal and trade policy intervention including continued efforts to stabilize Rupee value, by the Government to stabilize the export of Medicine and Medical Products to Africa, which has seen a sharp decline due to rising shipping tariffs caused by ongoing geopolitical conflicts.
Source: bit.ly/3Q8qlvT

Threefold Increase in FDI in Healthcare and Medical Device Sector in India during latter half of FY 2023-2024
Foreign Direct Investment (FDI) into the Hospital and Diagnostic Sectors in the country has increased by about 90% in the last quarter of 2023-24, as compared to the same quarter the previous year. Moreover, the Medical and Surgical Implements Sector has also seen a nearly 1/3rd growth by proportion during the same time. The total FDI received in hospital and medical devices sector stood at USD 462 Million.
Source: bit.ly/3U6Km70

Modern medicine Doctor body Expresses Concerns regarding Introduction of Integraded School of Medicine as Treatment
The Indian Medical Association, a professional representative body of Doctors, has expressed its concerns regarding the proposal of the Central Government to institute Integrated Medicine, which would offer treatments which are a mix of allopathic, homeopathic and traditional medicine. The Council expressed concern that due to the vast gulf in the manner of training, specialization and expertise between the various schools of medicine means that integration and cross practice treatment may pose severe risk to patient.
Source: bit.ly/3U6yi5E

EU and Japan harmonize Pharmacopoeia for ease of doing Business and regulatory Burden
The European Directorate for the Quality of Medicine and Healthcare, and the Japanese Ministry of Health, Labour and Welfare have entered into a Memorandum of Cooperation and Confidentiality, to coordinate efforts to harmonize the European and Japanese Pharmacopoeia, a move that would reduce the regulatory burden on manufacturers operating in the twin jurisdictions, with respect to carrying out compendial tests and IP approval.
Source: bit.ly/3UmRBJo

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy  reading it.

Draft GDP guidelines for pharmaceutical products published for comments
India’s Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document titled “Guidelines on good distribution practices for pharmaceutical products” for comments. The Guidelines seek to eliminate the introduction of spurious, adulterated, misbranded and non-standard quality (NSQ) products into the market. It is intended to be applicable to all entities involved in any aspect of the storage and distribution of pharmaceutical products, including manufacturer as well as pharmacists and any other person dispensing medical products directly to a patient.
Source: bit.ly/4cQwypM

Agreements with Shared Workspace Providers accepted as valid proof of premises for obtaining food licenses
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has issued an advisory on the documents that may be submitted as proof of premises by importers, traders, e-commerce entities, re-labellers etc. who deal in food products and operate out of a shared workspace premises. Going forward, any legally valid agreement with workspace provider will be accepted. Such agreement may be a lease or rent agreement. However, entities who operate out of shared work-space will not be able to stock food products in shared workspace under the license.
Source: bit.ly/3JkMpzp

Documents which will be accepted as proof of possession of premises for food business is specified by Central Food Regulator
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has identified documents which will be accepted as proof of possession of premises by a Food Business Operator (FBO) as part of the food license application. Any food business operator, undertaking any business of food or beverage, including hotels, restaurants, food vending establishments, clubs, canteens, importers, merchant, exporters, e-commerce operators, transporters has to submit proof of possession of premise in order to obtain corresponding food license.
Source: bit.ly/3UiCgte

Waste management portals for plastic packaging and e-waste to get operational in a phase wise manner
India’s Central Pollution Control Board (CPCB) has clarified that the Extended Producer Responsibility portals for the management of Plastic Packaging waste and E-waste will get operational in a phase wise manner. For plastic packaging waste the portal is only functional for Chandigarh, Chhattisgarh, Goa & Puducherry whereas for e-waste the portal is operational for Maharashtra only. The users of the portal for other states are requested to wait till further notice.
Source: bit.ly/3JqZRBH
Source: bit.ly/3Jl1Es4

Popular protein supplements sold in India found to have lesser quantity of protein than declared on the label
A recent study has found that many popular brands of protein supplements sold in the Indian market do not have the same amount of protein as claimed on the label. In addition to the inconsistencies related to protein content, the study also found evidence of protein spiking, fungal toxins, pesticide residues, presence of heavy metals and compounds in protein supplements manufactured in India.
Source: bit.ly/3vU24CC

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Guidance for making regulatory applications for biological and biotechnology products such vaccines may be revised soon
India’s central drug regulator, Central Drugs Standards Control Organization (CDSCO), has issued draft of revised guidance which seeks to align the online regulatory application process with applicable law i.e. The New Drugs and Clinical Trial Rules, 2019. Recently, the CDSCO has started accepting regulatory applications through NSWS portal. All stakeholders have time until April 25, 2024 to submit their suggestions/comments.
Source: bit.ly/3JlwIrU

Indian Pharma industry has sought clarity from Government on ethics of sponsoring foreign trips of doctors to attend scientific and training programs outside India.
An industry group representing multinational pharma companies has reportedly approached the Indian Government for seeking clarity on the issue of Indian doctors being sponsored by pharma companies for attending medical events outside India. A recent guidance issued by Department of Pharmaceuticals called Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) has stated that pharma companies will not sponsor travel and hospitality of Doctors unless they are speaking in medical events.
Source: bit.ly/3JklqnG

New Guidance document for generation and transfer of EPR Certificate under E-Waste Management Rules issued
India’s Central Pollution Control Board has issued a guidance document which explains steps to be taken by recyclers, recycling facilities under the E-Waste (Management) Rules, 2022 for generation of EPR Certificate. It has been clarified that EPR Certificate will have validity of 2 years. All importers and manufacturers of electric and electronic equipment including medical devices are required to procure EPR Certificates from registered recyclers to discharge their respective Extended Producer Responsibility obligations.
Source: bit.ly/44242Oc

Nestle wins class action suit filed by Government in the infamous Maggie Noodles case
The National Consumer Disputes Redressal Commission (NCDRC) has dismissed the Indian government’s 2015 complaint against Nestlé India over the safety of its Maggi noodle products. The Indian government had accused Nestlé of engaging in unfair trade practices by adding a ‘No added MSG’ label and claimed that the instant noodle product contained impermissible lead levels. However, NCDRC has noted in its order that the lead content in the tested instant noodle products was within permissible limits and that the Food Regulator itself had permitted brands to carry No Added MSG label if MSG was not deliberately added by manufacturer during the manufacturing process.
Source: bit.ly/3vIR1MJ

US based telehealth companies penalised for selling personal information
The United States Federal Trade Commission has reportedly taken action against an alcohol addiction telehealth company, for sharing health information to third parties including some major social media companies and search engines. A proposed order to settle the allegations will prevent the company from disclosing sensitive data for advertising purposes, among other penalties.
Source: bit.ly/43ZfoCi

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Manufacturers of tobacco products required to register their packing machine(s) with tax authorities
India’s Central Board of Indirect Taxes and Customs (CBIC) has postponed the timeline for manufacturers of tobacco products such as pan-masala, chewing tobacco, smoking mixtures, etc. to report their production capacity. CBIC had in January this year announced that producers must register their filling and packing machines and report these details. The measure was set to be implemented from 1st April 2024. However, the new effective date for implementation of the timeline is now 15th May 2024.
Source: bit.ly/3xz7400

NPPA releases draft ceiling price calculation sheets of seven scheduled formulations
The National Pharmaceutical Pricing Authority (NPPA) has published a preliminary calculation of ceiling prices for seven drug and vaccine formulations, inviting feedback from stakeholders within a ten-day period. These ceiling prices have been adjusted to reflect the minimum and maximum market prices of the products, in accordance with the updated Schedule I of the Drugs (Prices Control) Order, 2013, aligning with the National List of Essential Medicines (NLEM), 2022. The move shall be affecting major pharmaceutical giants in the business of ORS, vaccines and more.
Source: bit.ly/3UhjK4J

High Courts should interfere only when the case in lower court was decided by fraud or collusion: Supreme Court of India
While deciding an appeal against the order of the High Court, the Supreme Court of India observed that the High Court should apply care and caution while entertaining the petitions under Article 226 of the Constitution. The Court further explained that, in case of an already available alternative statutory remedy, the High Court should interfere in the matter only when the case is decided by fraud or collusion, otherwise an order in the same matter by the High Court will mean reopening the issues that have achieved finality.
Source: bit.ly/4cNGwIJ

Goa FDA to get the status of “US FDA observer” amid surge in increase in retail and wholesale licenses
The Goa Food and Drug Administration (FDA) has been extended the invitation to participate as “FDA observer” for inspections conducted by the USFDA India Office. This development came as a result of increase in retail and wholesale licenses issued by Goa FDA and their familiarity with the US FDA’s inspection process.
Source: bit.ly/3UfqIHq

Rejecting apology of the Directors of a Company for misleading advertisements, the Supreme Court sets caution for FMCG companies
Observing caution for fast-moving consumer good (FMCG) companies, the Supreme Court of India has refused to accept an apology from a major Indian Ayurvedic medicine manufacturer for misleading advertisements regarding its products in contravention of an undertaking provided to the Court. The Supreme Court stated that misleading advertisements by FMCG companies result in deceiving innocent consumers and play with public health.
Source: bit.ly/3PYqoKq

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Delay condonation should be evaluated based on reasons provided and not merits of case: Supreme Court
In a recent decision, the Supreme Court held that in condoning delay for a filing for which limitation period has been stipulated under the Limitation Act, 1963, a Court should not base its decision on whether such delay has been condoned in a similar matter, evaluating delay on merits of the fact situation, but rather each delay should be evaluated on the grounds pleaded in the application for its condonation.
Source: bit.ly/49MllnH

Central Government to take strict action against non-compliance with quality maintenance in manufacture of fire-resistant fabrics raw material
The Indian Central Government is intending to take stringent action against violators of the Bureau of Indian Standards (BIS) Quality Control Order for raw material used to manufacture fire-resistant fabric used in upholstery used in commercial spaces such as cinema halls, conference halls etc. Pursuant to issue of this Quality Control Order, only those raw material that have been certified by the BIS may be used in manufacture of commercial space upholstery. However, this Quality Control Order does not apply to upholstery used in households or those manufactured for export.
Source: bit.ly/4cKT4R3

Indian Government partners with Quality Council of India to improve services at Central Government run hospitals
India’s Central Ministry of Health and Family Welfare has entered into a Memorandum of Understanding with the Quality Council of India, to help improve quality standards for healthcare delivery at government run hospitals and help the hospitals get accredited by the National Accreditation Body for Hospitals/ Laboratories.
Source: bit.ly/3Ub0ful

Prices of imported Active Pharmaceutical Ingredient see sharp decline due to action against cartelized manufacturers
Despite an increase in demand in the Indian domestic pharmaceutical manufacturing sector for Active Pharmaceutical Ingredients (APIs), indicated by a 39% increase in year-on-year imports, the price of APIs being imported from China and other countries has reduced significantly to pre-COVID levels. This reduction is suspected to be caused by breaking-down of manufacturing cartels. This reduction in prices of API signifies an increase in profit margins for Indian firms which have traditionally been depended on Chinese imports.
Source: bit.ly/43Qlo0d

ECHR holds that inaction against climate change may be considered violation of human rights
The European Court of Human Rights has issued an award in favour of several Switzerland based petitioners who brought claims against their Government. The Court held that the European Convention on Human Rights envisages citizens right to be protected by their government against adverse effects of climate change. The petitioners had claimed that the inaction of the Swiss government and insufficient mitigation measures had caused a violation of the petitioners’ human rights, since such inaction by the government has increased their likelihood of dying of heat stroke.
Source: bit.ly/3JbMLZ6

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Indian Government may soon have to explain why traditional medicines are outside the scope of its flagship Universal Health Coverage scheme, or include it

India’s Delhi High Court has directed the Indian Government to provide reasons for excluding ayurveda, yoga, and naturopathy treatments are not covered by its Universal Health Coverage scheme (Ayushman Bharat) or if there is a plan to include it, then describe the steps for including them. The direction was issued in response to a Public Interest Litigation (PIL) Petition.
Source: bit.ly/43R0pdJ

Applications invited from private medical device testing laboratories to enable them to test medical devices on behalf of manufacturers
In a first of its kind development, India’s central medical device regulator, Central Drugs Standards Control Organization (CDSCO), has published a notice on its website inviting private medical devices testing laboratories to submit applications for obtaining licenses to test medical devices on behalf of manufacturers. Medical devices cannot be sold after manufacturing without testing by an in-house or external lab, and micro and small-scale manufacturers of medical devices are finding it a challenge to get their medical devices tested due to shortage of private medical testing laboratories.
Source: bit.ly/3TNyMNV

Right against adverse effects of climate change is now a fundamental right of Indians
The Supreme Court of India has interpreted Article 21 of the Indian Constitution, which recognizes the right to life and personal liberty, to include right against adverse effect of climate change. The Supreme Court’s interpretation came in a controversial litigation where the Court had to balance the need to take urgent steps to conserve Great Indian Bustard (GIB) with the need to use land inhabited by GIB for use to generate renewal solar and wind energy.
Source: bit.ly/3vHjIJU

Extension granted to foreign manufacturers of high-risk food products such as nutraceuticals, infant food, milk products for registration with Indian food authority till 31st August, 2024 
India’s central food regulator, Food Safety and Standards Authority of India (FSSAI), has extended the timeline for registration of foreign facilities which manufacture high risk food products, until 31st August, 2024. The high-risk food products are nutraceuticals, infant food, milk and milk products, meat and meat products (including poultry, fish and their products) and egg powder.
Source: bit.ly/3U8vEOd

Study indicates that more than half of cancer drugs which receive accelerated approval do not demonstrate clinical benefit in confirmatory trials
A study published in the Journal of the American Medical Association indicated only 43% of cancer drugs which were granted accelerated approval have demonstrated a clinical benefit in terms of patient survival or quality of life in confirmatory trials conducted in US. Accelerated approvals or early approvals are marketing approvals granted by Regulatory Authorities to drugs which show promising initial results for treating debilitating or fatal diseases.
Source: bit.ly/3U5XGd8

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Indian government intends to create a new AI law to protect news publishers’ rights
The Indian government plans to introduce a new artificial intelligence (AI) law that will safeguard the rights of news publishers and content creators while also minimizing harm to users. The new law will reportedly also have provisions for sharing the ‘proceeds’ among news publishers, content creators and AI-enabled technologies.
Source: bit.ly/4aF3DmM

Decrees from civil courts may be legally binding on criminal court in the matter of sentences and damages
The Supreme Court of India has held that while the outcome of civil law proceedings would not command the results of criminal law proceedings, they would have a significant influence on the latter while considering sentences or damages in such proceedings. However, such influence will operate only to the extent of holding the sentences or damages arising out of criminal proceedings as unsustainable in law.
Source: bit.ly/4aHiUmX

FDI inflow in pharma sector declines for FY 2023-24
The Foreign Direct Investment (FDI) equity inflow into the pharmaceutical sector has reportedly seen a decline of fifty percent (50%) in the first nine months of the Fiscal Year 2023-24 as compared to Fiscal Years 2022-23. The decline in FDI inflow during the FY 2023-24 comes after a significant growth of 45% reported for the 12 months ending in March, 2023.
Source: bit.ly/4aFlQ3F

DTAB plans to mandate free medicine from pharma companies as part of CSR
The Drugs Technical Advisory Board (DTAB) plans to amend the Drugs Rules, 1945 to include a requirement for pharmaceutical companies to donate at least one percent (1%) of their net profits to the distribution of free medications in medicine banks which will then be used by the Central and State governments at times of illness, calamity, or any other situation, as per necessity. A comparable amendment was proposed by DTAB in 2018 as well, however, it was only voluntarily implemented during that year. DTAB is a committee constituted by the Central Drugs Standard Control Organisation (CDSCO) entrusted to make policy decisions and send recommendations to the government of India in relation to technical aspects of the Drugs and Cosmetics Act and Rules. 
Source: bit.ly/3J4K8sb

Government introduces Ayushman Bharat Health Accounts to digitize health records
The Indian Government has introduced the Ayushman Bharat Health Account (ABHA) as part of its national healthcare scheme, aiming to digitize health records with unique account numbers and to enhance fund accessibility, medical transparency and easy upkeep of medical records. ABHA will be used by government hospitals, however, private hospitals will have the option to use ABHA for the creation and linking of health records making it non-binding at present.
Source: bit.ly/49nSHsM

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”
India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory to e-commerce websites, requiring them to ensure that proprietary foods, i.e. foods that are not categorized under the Food Standards Regulations, specifically those currently registered as analogues to milk/ cereal/ malt based beverage, should not be advertised as “Health Drink”/ “Energy Drink”, as only carbonated/ non-carbonated water-based flavoured drinks are regulated as “Health Drink” and “Energy Drink”.
Source: bit.ly/3xlfzvD

Drug Price Regulator may examine prevalent drug substitution and discounting prices offered by major drug retail stores in India
The Indian Central Drugs Regulator (CDSCO) has reportedly requested the Central Drugs Price Regulatory Body (NPPA) to investigate drug substitution and discounting practices of a major pharmacy chain on the basis a complaint raised by State Chemists and Druggists’ Association of the State of Karnataka (KCDA). In its complaint, the KCDA has alleged that the major pharmacy chain has been deliberately undercutting prices, sustained by substitution of prescribed drugs with other cheaper but identical formulations and unreasonably increasing its profit margins, which is currently violative of regulations applicable to pharmacists, as well as pricing norms of drugs.
Source: bit.ly/4cJSJOg

Vaccine manufacturers may have to provide manufacturing and sales data to government soon
The advisory body to India’s Central Drugs Regulator, the Drugs Consultative Committee, has requested various State-level Drug Licensing Authorities to ensure submission of details of the manufacture and sale of vaccines within the states to the Central Drugs regulator (Central Drugs Standards Control Organization), for the purpose of meeting obligation for the Global Benchmarking of Vaccines of the World Health Organization.
Source: bit.ly/3PJkAEw

Major Ayurvedic Medicine manufacturer may be on hook for contempt of court after Supreme Court rejects its apology for publishing misleading advertisements
In its ongoing proceedings against a major Ayurvedic medicine manufacturer for publication of misleading advertisements in contravention of undertaking given by it to the Supreme Court, the Court has refused to accept the apology which was tendered by the manufacturer, and rejected submissions of the manufacturer that: (1) The restriction on advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is archaic and may be relaxed since the manufacturer now has scientific data to back its claims, and (2) that the manufacturer should not be held liable for an advertisement issued by an independent marketing department.
Source: bit.ly/4akJen5

Australia updates Medical Device Recall Procedure
The Australian Therapeutics Goods Administration, which regulates medical devices at the central level in the country, has published a revised version of the Uniform Recall Procedure for Therapeutic Goods (URPTG), which relaxes regulatory burden of importers and manufacturers of medical devices. The revised URPTG provides additional clarity on procedure for immediate recall, clarifying timing of release of recall information by the regulator, modifying Customer Response Forms, and eases the filing requirements under the law by making all templates for recall action publicly available on the website of regulator.
Source: bit.ly/3TAZJEo

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Corporate hospitals may soon have to comply with advertisement norms applicable to doctors

India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the position that all hospitals should comply with the same standards of ethics as are applicable to doctors under the NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023. The operation of 2023 Regulations is currently under suspension.
Source: bit.ly/3vpJ7aV

High Court imposes damages of 244 crores in Standard Essential Patents case

India’s Delhi High Court has reportedly imposed damages amounting to INR 244 Crores on an Indian smartphone manufacturer. The Court found smartphone manufacturer guilty of infringing seven patents on 2G, EDGE, and 3G technology granted to a global telecom company. The order is expected to be out soon.
Source: bit.ly/3TxOXyI

Drug Manufacturers will have to upload all product details on Government portal soon

The Drugs Consultative Committee (DCC), a committee comprising State-level Drug Regulators, has recommended that the Central Drugs Regulator, Central Drugs Standard Control Organization (CDSCO), should set a deadline for manufacturers of drugs to upload list of drugs manufactured on an online portal called SUGAM.
Source: bit.ly/3TxP0uo

Ban on trade of ferocious dog breeds has been stayed in various States in India

India’s Kerala High Court, Karnataka High Court and Kolkata High Court has stayed a controversial circular of the Central Government which prohibited import, trading and selling of 23 breeds of dogs identified as ferocious in the circular. The circular also mandated sterilization of dogs from further breeding as pets. The circular has been challenged on the ground that it is unscientific, not based on evidence and has been issued without consultation with relevant stakeholders.
Source: bit.ly/3TVZcyi

European Medicines Agency urges sponsors of clinical trials to register on new portal before January 2025 deadline

The European Medicines Agency (EMA) has strongly advised sponsors of clinical trials that have been approved before 31 January 2023 to submit application to move the clinical trials to the new Clinical Trials Information System (CTIS) as soon as possible, considering it will take EMA up to three months to review and authorize the application. As of now, only 20% of clinical trials have been moved to the new platform.
Source: bit.ly/3TZRzHl

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

Criminal prosecution for drug related offences can start only on the basis of a drug inspector’s complaint: Supreme Court
India’s Supreme Court has confirmed that only a drug inspector, and not the police, is authorized to file a First Information Report (FIR) or a complaint for offence related to drugs under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/3PGkEVL

Drug prices may increase slightly due to increase in Wholesale Price Index
India’s drug price regulator, the National Pharmaceutical Pricing Authority of India, has communicated to the pharmaceutical industry that annual change in the Wholesale Price Index (WPI) in 2023 compared to 2022 was (+)0.00551%. Accordingly, manufacturers of drugs whose price are capped may increase their price by (+)0.00551% in the month of April without government approval.
Source: bit.ly/3xgzbRC

Drug labels may have to mention excipients which cause hypersensitivity soon
India’s top drug policy advisory body, the Drugs Advisory Board (DTAB), has directed India’s Central Drug Regulator, The Central Drugs Standards Control Organization, to prepare a list of excipients that cause hypersensitivity, with the intent that such excipients should be disclosed label of medicine. Other excipients will not have to be mentioned on the labels of medicine. Currently, the law does not require manufacturers to include to disclose information about excipients on the label of drugs.
Source: bit.ly/43E3M7D
Source: bit.ly/3vv1j2N

India low on Biopharma Innovation: Leading Industry Analyst
A leading industry analyst firm has written an open letter to Prime Minister of India that India seems to be ceding ground to its Asian peers in biopharma innovation and manufacturing. The firm has highlighted that India needs to encourage investment in biopharma manufacturing capacity, increase public health expenditure, and extend insurance coverage for the novel drugs, in order to promote innovation in biopharma space.
Source: bit.ly/3PHcD2N

High time to implement essential diagnostic guidelines to standardize diagnostic practices: Expert
Healthcare industry expert in India has emphasized the urgent need for the implementation of national essential diagnostic guidelines to standardize practices, improve patient care, streamline diagnostic processes, guide clinical decision-making, optimize resource utilization, and reduce healthcare disparities across India. In 2019, the Indian Council of Medical Research (ICMR) had issued the National Essential Diagnostic List (NEDL) to ensure consistency and quality in diagnostic procedures.
Source: bit.ly/3vyESd5