Healthcare & Pharma

Best Pharma, Lifesciences & Healthcare Law Firm in India

Indian Pharmaceutical Industry is the third largest in the world in terms of volume. The legal framework concerning the industry is generally under the microscope, from the actual effects of a certain product to the IPR. There are rules and regulations encompassing the intricate relationship between law and science. This sector is now being called the ‘Sunrise sector’ for its expectancy to expand tremendously over the next few years, moreover, it has been one of the most flourishing industries throughout the Covid-19 pandemic.

Though the healthcare system in India has several vulnerabilities, it goes beyond regulation to the matter of funding and the creation and maintenance of infrastructure.

Services Offered as Healthcare Law Firm in India :

KSK has curated a team of experts with a skillset to meet the requirements of Pharmaceutical and healthcare industry. The relevant skills allow the team to perform multitudes of legal tasks through services like

  1. Acquiring Licenses and regulatory approvals
  2. Cross-border transactions
  3. Dispute resolution
  4. Data protection
  5. Drafting and vetting agreements and other documents
  6. Ensuring compliance
  7. Enforcement of Intellectual Protection rights
  8. Patent filing
  9. Legal advisory
  10. Strategizing and implementing plan for setting up labs
  11. Dealing with claims
  12. Mergers and acquisitions

FAQs

Right to Health is not a separate fundamental right but a part of the Right to Life under Article 21 of the Constitution of India, thereby a fundamental right guaranteed to every citizen of India. It is concerned with access to medical services required by people in times of need despite their financial restrictions. Furthermore, It’s a part of the Directive Principles of State Policy under Part IV of the Constitution.

Pharmaceutical laws are concerned with the regulation of acts conducted by the pharmaceutical industry like manufacture, sale, distribution, and use of pharma products, research, and studies across the National and International bases.

The Pharmacy Act, of 1948 provides provisions to regulate the profession and practices of pharmacy. It also provides registration guidelines and specific information for the formation and conduct of the Pharmacy Council of India.

  1. The Drugs & Cosmetics Act, of 1940 regulates the import, manufacture, distribution, and sale of drugs in India. Under this act, there are specific schedules for specific purposes:
  • Schedule M provides a layout of the general and specific requirements of things of logistical importance such as factory premises and materials, plant and equipment, and areas for basic installation for certain categories of drugs.
  • Schedule T dictates GMP specifications for the manufacture of Ayurvedic, Siddha, and Unani medicines.
  • Schedule Y provides the clinical trials' legislative requirements.
  1. Research guidelines for human subjects have been laid out by the Ministry of Health, along with the Drugs Controller General of India (DCGI) and the Indian Council for Medical Research (ICMR). These GCP guidelines are developed by observing WHO guidelines, the Declaration of Helsinki, and ICH.
  2. As the name suggests, the objective of the Pharmacy Act, of 1948 is to regulate the profession of Pharmacy in India.
  3. The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 purposes control over advertising drugs by the prohibition of advertisements of remedies alleged to possess magic qualities.
  4. The Narcotic Drugs and Psychotropic Substances Act, 1985 is concerned with controlling and regulating operations relating to Narcotic Drugs and Psychotropic Substances.

 

The Department of Pharmaceuticals has been created in 2008 to tackle the issue of lack of affordable medicines, therefore it’s entrusted with the formulation and implementation of policies related to drugs, pharmaceuticals, dyestuff, and other intermediaries.  The National Pharmaceutical Pricing Authority (NPPA) enforces Drugs (Price Control) Order 1995 and other orders such as recovering overcharged amounts from manufacturers. The Central Drugs Standard Control Organization (CDSCO), developed under the Ministry of Health & Family Welfare, provides regulatory requirements in India such as responsibilities of the states and centre, approval for drugs, and uniformity in enforcing the drugs and cosmetics Act.

HOW CAN WE HELP?

The Firm has a team of lawyers who hold expertise in healthcare & pharma and is in position to provide you with unrivalled expertise on your healthcare & pharma legal assistance needs.
LITIGATION
The Litigation Team of the firm predominantly involves catering to the needs of Indian and Multinational clients
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REGULATORY
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 | Kolkata | Pune