Over the Counter drugs Regulations in India

Over The Counter (OTC) drugs are drugs that can be sold by pharmacists without a prescription from a Registered Medical Practitioner (RMP). Many drugs are sold over the counter without prescription, but the regulatory regime is grey in this regard, primarily because the term OTC has not been expressly defined under the Drugs & Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (D&C Rules). Regulatory ambiguity is set to change, however, as the Central Government is now actively considering regulating the sale and distribution of OTC drugs[1].

Continue Reading Over The Counter Drugs – Regulatory Clarity on the Horizon

 Securities Law Enforcement - Calibrating the Discipline of Penalty Imposition

Equipped with broad statutory powers, the Securities Exchange Board of India (SEBI) has been hard at work for the past 30 years, shouldering the herculean task of managing the Indian securities market, through both regulation and enforcement. Naturally, to help SEBI respond to and deal with evolving challenges, its powers, specifically those under the Securities Contracts (Regulation) Act, 1956 (SCRA) and the SEBI Act, 1992 (SEBI Act), have been continuously at play, allowing it to mete out a wide range of penalties, both monetary and substantive. SEBI’s exercise of such powers, in its capacity as a quasi-judicial authority, has increasingly become a subject-matter of appellate interest, on questions of both jurisdictional remit and proportionality of penal action. Continue Reading Securities Law Enforcement: Calibrating the Discipline of Penalty Imposition

 Decriminalising Companies Act Offences

Via the Companies (Amendment) Act, 2019, recommendations of the Committee to Review Offences under the Companies Act, 2013 (Committee) to re-categorise 16 out of 81 compoundable offences under the Companies Act, 2013 (Act) as civil liabilities were accepted. In a move to further relax the provisions, the Government has constituted a Company Law Committee to review aspects of criminalization in the remaining compoundable and non-compoundable offences under the Act.[1] Continue Reading Decriminalising Companies Act Offences – Striking a Balance Between Ease of Doing Business and Corporate Governance

  Taxation of REITs in India

 

*An eight-part series covering the commercial and legal considerations of REIT listings in India. Click here to read Part III.

The Government started putting in place a framework for taxation of business trusts even before the regulations governing Real Estate Investment Trusts (REITs) and Infrastructure Investment Trusts (InvITs) were notified by the Securities Exchange Board of India (SEBI). This was not without reason – progressive regulations and tax reforms have influenced the progress of REITs globally, with REIT markets witnessing sudden growth spurts in countries such as Singapore and Hong Kong almost immediately following favourable tax amendments.

Closer home, five years and multiple amendments later, the Indian tax regime for REITs is a complex proposition and comes with a wishlist from nearly all stakeholders involved in a typical REIT. With Indian real estate likely to provide investment opportunity worth up to USD 77 bn through REIT-eligible commercial office and retail properties across India’s top seven cities by 2020[1], there can be no better time to look at some of the key issues. Continue Reading Part IV – Taxation of REITs in India

Finance Act 2019 - Prevention of Money Laundering Act Amendment

The Finance Act, 2019 (the 2019 Act) is the Central Government’s endeavour to tighten the gaps around the existing provisions of the Prevention of Money Laundering Act, 2002 (PMLA). Amidst the growing number of financial crimes and high-profile cases, the 2019 Act attempts to make the existing provisions stricter and better armoured to detect suspicious transactions. Additionally, the Act, along with the other amendments, has a greater aim of targeting money laundering and terrorist financing. The 2019 Act attempts to remove the ambiguity in the existing provisions by amending eight clauses of the PMLA. Continue Reading PMLA Amendment 2019 – Plugging the Loopholes

Prevention of Air Pollution from Ships

The International Maritime Organization (IMO) developed the International Convention for the Prevention of Pollution from Ships (MARPOL Convention) with the aim of preventing pollution of the marine environment by ships. Regulations for the Prevention of Air Pollution from Ships are provided for in Annexure VI to the MARPOL Convention and they seek to control airborne emissions from ships by prescribing limits on emissions.

Today, the shipping sector accounts for 12% of global sulphur dioxide emissions, 13% of global nitrogen oxide emissions and 3% of global carbon emissions.[1] Shipping fuel constitutes 7% of the global transport oil demand – however, global shipping emissions account for 90% of the transport sector’s sulphur emissions. Continue Reading Laundered Air on the High Seas- IMO 2020

Oxytocin Ban in India

Oxytocin is life-saving drug that is used for the induction and assistance of labour in women during childbirth. It is also used to stop postpartum haemorrhage (excessive bleeding). The drug also aids milk secretion during the lactation process. Because of its inherent lifesaving properties in humans and cattle, Oxytocin is identified as an essential medicine in the 20th World Health Organization (WHO) Model List of Essential Medicines, March, 2017[i]. It also continues to be included as an essential medicine in the National List of Essential Medicines (NLEM), 2015[ii]. Continue Reading The Oxytocin Ban Story

Gujarat - A Re-emerging Pharma Destination

Gujarat has been the flag bearer of India’s pharmaceutical industry since the establishment of the country’s second oldest drug company, the Alembic Chemical Works Company Limited in Vadodara in 1907. Gujarat’s strategic location on the western coast, coupled with dynamic entrepreneurial talent and favourable policies from the State Government has led it to become one of the premiere industrial hubs for investors looking to invest in India.

Gujarat currently has 33 percent of the aggregate share of the pharmaceutical industry in India[1] and the State also accounts for at least 28 percent of the pharmaceutical exports from India[2]. Moreover, with the advent of the Goods and Service Tax (GST) coupled with the upcoming expiry of tax holidays granted by some northern states of India, the pharmaceutical industry is witnessing a jurisdictional shift, with some of the largest pharmaceutical companies looking to relocate or establish their manufacturing plants in Gujarat. Continue Reading Gujarat – A Re-emerging Pharma Destination?

The Karnataka Maternity Benefit (Amendment) Rules, 2019

The Maternity Benefit Act, 1961 (the Act) was introduced to regulate the maternity and related benefits that are extended to women in certain establishments for a period before and after childbirth.

In 2017, by way of the Maternity Benefit (Amendment) Act, 2017 (Amendment Act), various progressive changes were brought about to the law, such as an increase in maternity leave from 12 to 26 weeks, provision for maternity leave for adopting mothers and commissioning mothers, and the introduction of a work-from-home concept as part of an employee’s conditions of service.

Section 11A of the Act, which was introduced under the Amendment Act, made it compulsory for every establishment employing 50 or more employees to provide a crèche facility for its employees. The Amendment Act uses the term “employees” and not “women” thus leading to varied interpretations – for example, does “employees” include employees of all genders and does the Act apply to both permanent as well as contract employees? Continue Reading The Karnataka Maternity Benefit (Amendment) Rules, 2019: Good Intentions But Can It Be Implemented?

The Healthcare Service Personnel and Clinical Establishments Bill, 2019

In the backdrop of recent attacks and acts of violence against medical practitioners and a growing demand for protection in this regard, the Central Government is considering steps to ensure protection is granted to healthcare professionals and clinical establishments, by making such acts punishable offences under law. After numerous meetings with doctors and other stakeholders, the Department of Health and Family Welfare (Medical Services Division), of the Ministry of Health and Family Welfare, Government of India, vide notification dated September 2, 2019,  proposed a draft legislation titled ‘The Healthcare Service Personnel and Clinical Establishments (Prohibition of Violence and Damage To Property) Bill, 2019’ (the “Bill”). Continue Reading The Healthcare Service Personnel and Clinical Establishments (Prohibition of Violence and Damage to Property) Bill, 2019