The subject of life sciences is concerned with our bodily and mental well-being. Pharmaceuticals, clinical research, medical equipment, illness diagnosis and treatment, biomedicine, cell biology, and biotechnology are all included. This industry includes companies involved in commercialization, technology transfer, and research and development. Given India's expanded participation in the World Trade Organization during the last decade, the pharmaceutical industry in India has been compelled to embrace research and development-based growth strategy. In addition to manufacturing pharmaceuticals, India's pharmaceutical sector serves as a center for clinical production and research outsourcing. India can expand its export potential by strengthening intellectual property protection legislation and adhering to World Trade Organization norms. India might potentially become a global leader in advanced research and development, pharmaceutical development, and biotechnology. The government is striving hard to increase spending on scientific research and development from its current level. The pharmaceutical sector is currently undergoing consolidation, with smaller companies merging with larger competitors and nearly all established players seeking acquisitions to diversify their product and brand portfolios, increase market share, and reinforce their positions.
Services Offered:
King Stubb & Kasiva has been representing several reputed Medical Companies, Medicine Producers, Medicine Supplies, and Health Model Development Companies in India and providing them a wide array of services. Our services encompass both advisories as well as litigation-related matters.
The Firm represents a broad range of clients that are involved with health, medical & lifesciences sector, including:
Setting up Business & Acquisitions
Assistance in Setting up or acquiring a drug manufacturing facility.
Expert Advice
Partnering with experts in the field of Health and Information Technology, to ensure scientific and technological perspectives in the delivery of our services.
IP Protection
Securing manufacturing licenses and import licenses, fcilitating registrations of medical devices, formulating Trade Secret Protection Policies and facilitating the infrastructure for privacy and data protection.
Litigation Services
Assisting in Adverse Drug Reaction reporting and litigation support to the victims of Adverse Drug Reactions and medication errors.
Transfer Regulations
Importing specialised ingredients to manufacture health and beauty products.
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.
