In an earlier blog post, we took a close look at the National Medical Devices Policy, 2023 (“Policy”), notified by the Department of Pharmaceuticals (“DoP”) on May 2, 2023. We delved into the framework, objectives and core focus areas of the Policy. While the aim of the Policy was clearly to reduce import dependency and establish India as a global manufacturing hub for medical devices, little information was provided on the means to achieve these goals. To draw a holistic picture, we sought guidance from the Approach Paper to the National Medical Devices Policy, 2022 (“Approach Paper”), which was based on similar principles and furthered the same goals as the present Policy. However, the DoP has recently also issued a strategy document on the Policy (“Strategy Document”) to fine-tune and expand on its implementation strategies. In light of the same, this blog post analyses the Strategy Document, measures envisaged thereunder, enforcement priorities and focal points.Continue Reading The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation
Partner (Head - Pharma & Healthcare) is part of the General Corporate Practice at the Delhi NCR Office of Cyril Amarchand Mangaldas. With a specialist focus on intellectual property, pharmaceuticals / medical devices regulatory and compliance affairs, Ashwin has an extensive domestic and international experience of 19 years providing advice on matters relating to intellectual property, drug and medical device regulatory and compliance affairs, transactional affairs, anti corruption and anti kick back laws, litigation and dispute resolution. He can be reached at email@example.com
E-Pharmacies and operations thereof have been a contentious issue for long. While the issue remains static largely due to the delay in the notification of the E-Pharmacy Rules that were drafted in 2018, there is significant litigation that has ensued as well. The Government is contemplating whether e-pharmacies should be allowed to sell medicines online and, in this vein, the Drugs Controller General of India (“DCGI”) has issued show-cause notices to over 20 e-pharmacies to give them an opportunity to explain their operations and compliance with the regulations. As litigation ensues and rival contentions are presented before the courts, the Indian Government is currently seeking proper legal opinion on the regulation of e-pharmacies.Continue Reading The Operation of e-Pharmacies and Data Privacy Risks
In a bid to reduce import dependency and boost domestic production of medical devices, the Union Cabinet recently approved the National Medical Devices Policy, 2023 (“Policy”). The broad contours of the Policy were earlier notified vide a press release issued by the Press Information Bureau (“Press Release”). The Policy aims to reduce India’s import reliance and has a stated goal to establish India as a global manufacturing hub for medical devices. This announcement comes at a time when the Government is actively promoting the ‘Atmanirbhar Bharat’ and ‘Make in India’ initiatives.Continue Reading Medical Devices Policy, 2023 – A Vision to Streamline Regulation, Incentivise Domestic Manufacturing and Facilitate R&D
Price regulation of non-scheduled formulations has always been a contentious issue. While the Government can set prices of drug formulations that are listed on the National List of Essential Medicines (“NLEM”) – Scheduled Formulations, the Government can at best monitor prices of drug formulations that are not listed on the NLEM – Non-scheduled Formulations.
The Delhi High Court in its recent judgment in the matter of Bharat Serums and Vaccines Limited v. Union of India & Ors. provided much needed clarity on paragraph 20 Drugs (Price Control) Order, 2013 (“DPCO 2013”), which regulated the pricing of non-scheduled formulations and drugs, focusing on the legal implications ensuing from the breach thereof.Continue Reading Analysing Bharat Serums and Vaccines Limited v. Union of India & Ors. judgement
Advances in drug research over the years have resulted in the development of blockbuster drugs, which have increased the life expectancy of mankind. In the past decade, scores of patients across the globe suffering from rare or chronic ailments had limited treatment options due to unavailability / pending approval of life-saving drugs in their countries. From a legal standpoint, a drug is only permitted to be obtained and used by a patient once such drug has been granted the requisite approvals from the requisite drug regulatory authorities of such country after following proper clinical trial protocols that establish safety and efficacy of such drugs. With rising costs of drug trials, not every drug is submitted for approval in every country yet disease conditions that warrant use thereof still exist. Following representations from medical professionals and stakeholders to cater to such situations, drug regulators realized the need to ensure that such drugs are made available to those who need them irrespective of approval status. Currently, numerous expressions such as ‘usage on compassionate grounds’, ‘expanded access’ and ‘preapproval use’ exist to describe this concept and are used interchangeably. Continue Reading Use of unapproved drugs in India on compassionate grounds- Unravelling the Regulatory Conundrum
On May 02, 2022, the Hon’ble Supreme Court of India passed its judgement in a matter titled Jacob Puliyel v. Union of India & Ors, wherein it closely examined the details of the vaccination policy, the dissemination of clinical trials data, veracity of emergency approvals of vaccines and the reporting of adverse impacts of vaccination.Continue Reading Coercive Vaccination! Explaining the Jacob Puliyel v. Union of India case
The Covid-19 pandemic has wreaked havoc on mankind, infecting well over 13 million, and claiming over half a million lives. It has also severely impacted economies across the world. Our healthcare infrastructure has been pushed to its limits and our frontline healthcare professionals are working to the brink of exhaustion, risking their own lives to save others. We bow to them.
In the midst of all this, scientists across the world are working feverishly to find a vaccine for this disease. The hopes of billions rest on this. The World Health Organization (“WHO”) has (as of July 15, 2020) declared that there are about 23 potential vaccine candidates that are currently in various stages of clinical trials. Out of these 23 vaccines, vaccines being developed by: (a) Sinovac (inactivated +alum); and (b) University of Oxford / AstraZeneca has entered into the Phase-III of its clinical trials. In addition, as of July 15, 2020, there are around 140 vaccine candidates in preclinical evaluation (trials not commenced).
Continue Reading In Search of a Vaccine for Covid-19: A Race to The Finish
The pharma sector has gained renewed global attention due to the crisis brought about by COVID-19, a pandemic having an unprecedented impact on health and wellbeing of citizens across geographical boundaries. It is estimated that around 76 pharma companies across the world are in a race to develop and mass-produce an effective vaccine in the fight against COVID-19. Indian pharma companies too are playing a vital role in this search. The Indian pharmaceutical industry has responded to the rapid challenges arising from disruption in supply chains and is working in an integrated manner to drive local expertise by production and export of essential formulation to countries across the globe, and live up to its title as the ‘Pharmacy of the World’.
Continue Reading FDI in Brownfield Pharma – Will COVID-19 be the Catalyst for Policy Reforms?
The entire world has been grappling with the COVID-19 pandemic for some time now, and efforts are on to find a treatment protocol and vaccine. Several drugs and treatment therapies are being tried and tested to find a cure for this pandemic. In the middle of this fervent R&D activity, some questions come to mind — what about IP protection? How would companies commercialise a cure — if and when it is finally found? How would the cure be available to the public en-masse at affordable prices? Enter patent law and the aspect of Licencing.
Continue Reading To Protect or Not to Protect that is the Question : Patent Licensing in times of Covid-19 Pandemic
The COVID-19 pandemic has literally brought the world to a standstill. Large scale infections have resulted in lockdowns across the globe. At this critical juncture, testing continues to remain the most important step to get a grip over the situation. The situation in India is no different. With an upsurge in the number of COVID-19 cases in India, the need for largesse testing has become paramount. Low availability of test kits remains a cause of great concern to the government and healthcare practitioners. This is compounded by our massive populace, given the quantity that is required in the current scenario. This lack of availability of test kits is primarily because India does not have adequate indigenous manufacturing units of COVID-19 test kits and relies heavily on imported kits.
From a regulatory standpoint, such kits fall under the category of ‘in-vitro diagnostic’ kits under the Drugs and Cosmetics Act, 1940 (D&C Act) read with the Medical Devices Rules, 2017 (MD Rules) and are regulated as ‘medical devices’.
Continue Reading COVID-19 Test Kits. A Cheat Sheet