Drugs and Cosmetics Act

Cosmetics Regulation in India

Customised cosmetics have recently grown in popularity, with customers increasingly appreciating the value of personalised rather than off-the-shelf products. Customers often prefer to pick ingredients which suit their skin/ hair characteristics, and associate such unique products with greater effectiveness and functionality. Several cosmetics manufacturers and retailers are already in the race to capture this growing demand in India. However, little attention has been paid to the legal implications and regulatory risks which arise from the import, production, storage, mixing and/ or retail of such customised cosmetics. It is therefore essential for players in this emerging market to be mindful of certain important legal questions and considerations to ensure proper compliance. This is especially in light of the new regulatory landscape, which has been laid down through the Cosmetics Rules, 2020 (“Cosmetics Rules” / “Rules”) and has been rapidly evolving over the past few years.Continue Reading Concept to Compliance: Unveiling the Untapped Realm of Customised Cosmetics Regulation in India

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[1].    Continue Reading Use of unapproved drugs in India on compassionate grounds- Unravelling the Regulatory Conundrum