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
Principal Associate in the Pharmaceutical, Life-sciences and Healthcare practice at the Delhi office of Cyril Amarchand Mangaldas. Akshat specializes in regulatory compliance, advisory work and litigation pertaining to the pharmaceuticals, life sciences and healthcare sector. He has a wide range of experience in advising clients on litigation and transactional issues across various sectors including, Oil & Gas, Financial Institutions, Ports, Hydro, Warehousing, Aviation, etc., having worked previously in dispute resolution and projects practice at the firm’s Delhi office. He can be reached at firstname.lastname@example.org
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
India is yet to come of age as far as the nuclear sector is concerned due to sustained lack of support from the International Atomic Energy Agency (“IAEA”), and exclusion from the Nuclear Non-Proliferation Treaty (“NPT”) and Nuclear Suppliers Group (“NSG”). In 2014, a few nuclear reactors like Narora, Kudankulam and Kakrapar were brought under the IAEA safeguards. However, the Additional Protocol of 2014 allowed the IAEA enhanced access to India’s facilities, but this was limited to only the reactors included under the safeguards. As a result, a majority of nuclear power plants in the country are still untapped, which has led to a bearish curve in the investment inflows in the country, on account of lack of both financial commitments and savvy technology.
Globally, the United States of America (“US”), France, Russia, South Korea and China are also among the biggest nuclear power generating countries. Out of their energy pool, nuclear energy comprises of one-fifth of the energy usage for US and Russia, seventy five percent for France, thirty percent for South Korea and four percent for China. For India, nuclear energy consists of three percent of its energy pool, and is predicted to rise to six percent by 2030.
Continue Reading Fractional Deregulation: Spurring The Nuclear Doctrinaire
In part one of this two-part blog series, we looked at the challenges and new approaches that are being devised to increase the share of natural gas in India’s energy market, including some of the challenges faced in effectively implementing the “Authorising Entities to Lay, Build, Operate or Expand City or Local Natural Gas Distribution Networks – Amendment Regulations, 2018” (2018 Amendment Regulations).
In this piece, the second part of this two-part blog, we look into how the 2018 Amendment regulations will work in practice, to provide a balance between expansion of the natural gas industry and consumer interest – while also supporting the development of the right infrastructure to ensure the smooth supply of gas.
Continue Reading City Gas Distribution: Creating Demand for India’s Energy Future – The Balancing Act
Just as the bidding closed on the 10th Round of the City Gas Distribution (CGD), fundamental changes have been made to the bidding criterion to create a regime that strikes a balance between the for-profit enterprises, and public interest and accountability.
In this first part of a two-part blog series, we assess these changes and the challenges faced in meeting targets to increase the share of natural gas in India’s energy market.
Continue Reading City Gas Distribution: Creating Demand for India’s Energy Future – Changes to Support the Shift to a Gas Economy
The Exploration and Production (E&P) basins usually mature in about 20-30 years. What is left after the prolonged E&P phase are the abandoned installations and wells (onland), sub-sea infrastructure, platforms, and wells (offshore). Once the hydrocarbon resources are exhausted or it becomes unviable to extract them further, the E&P project moves to an abandonment phase, and the project is decommissioned. Decommissioning ensures that the E&P installations and infrastructure are removed subsequent to their abandonment and the site is restored in an environmentally sustainable way.Continue Reading Decommissioning Of Oil and Gas Production Fields on High Seas
According to World Health Organization (WHO), seven cities in India are positioned among the most polluted cities in the world. In these circumstances, the need of the hour, among other solutions, is to switch to a cleaner and more sustainable fossil fuel, for instance, liquefied natural gas (LNG). The combustion of natural gas does not emit soot, dust or fumes, and thus it makes it one of the cleanest fossil fuels with high energy to carbon ratio.
Continue Reading LNG as Transport Fuel in India