In India, import, manufacturing, sale and distribution of drugs and medical devices is regulated under the Drugs & Cosmetics Act, 1940 (the Act), Drug & Cosmetic Rules, 1945 and Medical Devices Rules, 2017. The registration of both drugs and medical devices are processed by the Central Drug Standards Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare. CDSCO serves parallel function to the European Medicines Agency of the European Union, the MFDS or KFDA of Korea, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.

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News/ Experience
Across all of our practice areas, our teams are trusted for their concrete client focus, broad experience and wealth of knowledge. The recent work below demonstrates their winning contribution to significant cases, and ability to facilitate complex transactions.
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Registration & Licensing System of Drugs and Medical Devices in times of COVID-19
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Implication of COVID-19 on Business Contracts
The outbreak of coronavirus has caused, and continues to cause, uncertainty for organisations operating in the region alongwith the businesses across the world that rely on China for trade, manufacturing and supply chain. Due to the shutdown, mandatory quarantine for travelers and the country’s focus on controlling the outbreak, those who do business in the region are facing growing uncertainty and volatility in the market.
Businesses who have been affected are now seeking to understand their rights and obligations and any relief that might be available to them. Often the first thought that comes to mind in such circumstances is a ‘force majeure’, ‘frustration’ or impossibility clause, which is typically agreed between parties in manufacturing and supply contracts to allow a period of relief to the performing party from the consequence of any circumstances that may arise which are beyond their control.
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India's gift to coal mining, contact manufacturing, digital media and single brand retail trading
The Cabinet Ministry has announced series of reforms through press release dated 28 th August 2019 1 , towards development of commerce and industry in India and as cabinet minister Piyush Goyal said, with an aim to “liberalise and simply the FDI policy to provide ease of doing business in the country, leading to larger FDI inflows and thereby contributing to the growth of investment, income and employment”. The press release introduces reforms in four major sectors, i.e. coal mining, contract manufacturing, digital media and single brand retail trading.
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What constitutes a Non- Banking Financial Company?
A Non-Banking Financial Company (“NBFC”) is a company registered under the Companies Act and engaged in the business of loans and advances, acquisition of shares/bonds/securities, leasing, insurance business, etc.
Typically NBFCs do not accept public deposits, however, upon procuring approval from Reserve Bank of India (“RBI”), they may accept public deposits. The Reserve Bank of India Act, 1934, (“Act”) defines “non-banking financial institution” (“NBFC”) as any one of the following entities:
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Active Companies Tagging Identities & Verification
The Central Government in exercise of its powers has amended the Companies (Incorporation) Rules, 2014 and on 21st February 2019 introduced the Companies (Incorporation) Amendment Rules 2019 (Amended Rules) that came into force with effect from 25th February 2019. The Amended Rules have been initiated to identify those companies that are registered under the Companies Act but are not performing any business activities. The Amended Rules has inserted a new rule “Active Company Tagging Identities & Verification (ACTIVE)” to the Companies (Incorporation) Rules, 2014, directing every company incorporated on or before 31st December 2017 to file e-form “INC-22A” with zero fees on or before 25th April 2019.
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Non-Executive Director’s Pay
A company’s activities and direction are headed and managed by its directors. These directors are directly responsible for the growth of the company and better management, including formulating long-term plans and managing day-to-day activities. The Companies Act, 2013 (“Act”) recognises various classes/categories of directors, however, such classes can be classified under two broad categories, i.e., ‘executive director’ and ‘non-executive director’.
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Legal Issues in the uncapitalized industry for adult toys in India
The sexual wellness industry or the adult products industry is a multi-dollar industry worldwide, however, its market in India is barely touched and not fully utilised. The moral, cultural and legal connotations attached to such products create hindrance to market them in India. E-commerce platform offer privacy, discreetness, convenience, home delivery options, affordable pricing etc. which make them suitable for dealing in such lifestyle products. In recent years, very few start-ups have been able to launch online stores dealing in sexual wellness and lifestyle products such as condoms, lubricants, gels, products meant to promote sexual pleasures such as adult toys, role play costumes, board games etc.
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Legal Issues when starting a business
In essence, starting a new venture (start-up) can be both exhilarating and thrilling. But it can also be cumbersome since various obstacles originates while starting acompany from basics. Such hurdles may be statutory such as incorporation of a company or may relate to other aspects of business such as procuring financing. It is often seen that people miss or forget some fundamental steps while processing their business incorporation and growth. Fear not, following key points will help you guide through the legal pits towards setting up of your business:
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Cloud Kitchen : The next big thing in future
Cloud kitchens, aka ghost or virtual kitchens, are the recent addition to the rapidly growing Food and Beverage Industry. Based on the model of no dine-in and take-away services, the concept of cloud kitchens has gained enormous popularity and success in recent years with an astonishing projected market size of USD 1.05 billion by 2023. These estimates are also supported by food delivery industry’s growth rate of 150% in recent years. Unlike the traditional restaurants having a brick and mortar shop set- up, cloud kitchens function on internet-based delivery system by bringing the brand to the customers instead of the customers coming to the brand.
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Non-systematically Important Non-deposit Taking Nbfc
Non-Banking Financial Companies (“NBFC”) are broadly categorised under the following three categories. These three categories are taken together to frame policies and framework that govern the operations and future of the respective NBFC.
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Disqualification Of Directors Under Section 164(2) Of The Companies Act: Delhi HC Interprets The Law
Delhi High Court has clarified the position of law in disqualification of directors under section 164(2) of the Companies Act. Under the said section, directors of companies that have defaulted on filing financial returns for 3 consecutive years are disqualified from being appointed as directors for 5 years.
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Government to exempt startups from regulatory filings for 10 years
To boost entrepreneurship in India, the government is planning to announce extensions in a series of exemptions for startups.