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Lifesciences legal services

King Stubb and Kasiva is your trusted partner for comprehensive lifesciences legal services in India. Our team of dedicated legal professionals is here to provide you with the expertise and guidance needed to navigate the ever-evolving landscape of lifesciences law. Our lifesciences legal services are tailored to meet the specific needs of this dynamic industry.

The lifesciences sector is a nexus of innovation, where research, development, and regulation intersect. In this dynamic industry, legal considerations are paramount. Whether you are a pharmaceutical company, a biotechnology startup, a healthcare provider, or involved in any lifesciences-related endeavor, our lifesciences legal services in India are tailored to meet your specific needs.


The Drugs and Cosmetics Act 1940 and the Drugs and Cosmetic Rules 1945 govern pharmaceutical and cosmetic manufacture, distribution, import, export, and clinical research. The Central Drugs Standard Control Organization regulates pharmaceutical commodities. The drug controller general of India registers all novel pharmaceuticals, imported drugs, and drugs that fall under particular categories. It is also in charge of quality control and clinical research. The state licensing authority is largely responsible for quality control and inspection, in addition to accrediting industrial establishments.

All medicines and drugs must be licensed by a licensing authority before they may be distributed or sold commercially. The same is covered by Rule 122(e) of the Drugs and Cosmetics Rules of 1945. Any novel drugs must be approved by the Central Licensing Authority. After receiving initial clearance or being added to the Indian Pharmacopoeia, a new drug is deemed new for four years. State regulatory bodies can grant manufacturing approvals once pharmaceuticals are no longer considered novel. To request approval for a new medicine, fill out Form 44. Permissions must be obtained on Form 44 and submitted to the licensing authority at 50,000 rupees to import a new drug.

Following an inspection, the Indian Drug Controller General approves the production facility and issues a Registration Certificate. Following a site inspection, state licensing organizations can issue manufacturing licenses. The manufacturer must follow the good manufacturing practices outlined in Schedule M of the Drugs and Cosmetics Rules, as well as the ICH Q6A quality standards. The second schedule of the Drugs and Cosmetics Act lists the conditions that Indian-made and -marketed medications must meet.

The penalties for producers who sell pharmaceuticals in contravention of the limits are outlined in Section 27 of the Drugs and Cosmetics Act of 1940. If it is determined that a drug is tainted or counterfeit and is likely to cause death or serious harm, the Act allows for prosecution under the Indian Penal Code; such offences are punishable by imprisonment and a fine. In addition to imprisonment and a fine, Section 31 of the Act allows for the confiscation of property. Only an inspector or any gazette officer of the federal or state governments authorized in writing on behalf of the federal or state governments by general or special order, or a person aggrieved or a recognized consumer association, may bring charges under the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetic Rules of 1945. Offences under the 1940 Drugs and Cosmetics Act are prosecuted in special courts.

According to the Code of Pharmaceutical Practices 2012 of the Organization of Pharmaceutical Producers of India, member companies are not permitted to give medical practitioners gifts or cash grants for personal use in their roles or under any other pretext. The Uniform Code of Pharmaceutical Marketing Practices is a comprehensive code on pharmaceutical marketing methods. The Uniform Code of Pharmaceutical Marketing Practices forbids pharmaceutical corporations from giving gifts, monetary benefits, or in-kind benefits to individuals licensed to prescribe or provide medications. Gifts for the personal profit of medical practitioners are also not permitted to be presented or provided.




The Firm has a team of lawyers who hold expertise in lifesciences and is in position to provide you with unrivalled expertise on your lifesciences assistance needs.


The Litigation Team of the firm predominantly involves catering to the needs of Indian and Multinational clients


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We regularly represent corporate and individual clients before state and central administrative agencies

King Stubb & Kasiva

Offices In - New Delhi | Bangalore | Mumbai
Chennai | Hyderabad | Kochi | Pune | Mangalore

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