Vidhikrit Legal

Pharma & Healthcare

The pharmaceutical industry in India is valued at an impressive $50 billion, making India a significant global exporter of pharmaceuticals to over 200 countries. We are proud to be at the forefront of this thriving sector, with our expertise providing end-to-end assistance to clients in this field.

At Vidhikrit Legal, we offer specialized services to the pharmaceutical industry, covering a wide range of legal matters to ensure compliance and protection in this highly regulated sector.

How can we help?

  1. Regulatory Compliance: We provide expert advice on navigating the complex web of laws and regulations governing pharmaceuticals, medical devices, clinical trials, drug pricing, and marketing practices. Our services include obtaining necessary licenses, approvals, and registrations.
  2. Intellectual Property Protection: We assist in safeguarding intellectual property rights related to pharmaceutical products, formulations, patents, trademarks, and trade secrets. This includes patent filings, oppositions, and handling infringement cases.
  3. Drug Licensing and Approvals: Our team offers guidance on obtaining licenses, permits, and approvals from regulatory authorities, such as the Central Drugs Standard Control Organization (CDSCO), for drug manufacturing, import, distribution, and sale.
  4. Clinical Trials and Research: We help clients navigate the legal framework for conducting clinical trials, ensuring compliance with informed consent procedures, ethics committee approvals, data privacy, and Good Clinical Practice (GCP) guidelines.
  5. Pricing and Reimbursement: Our experts advise on drug pricing regulations, government pricing policies, price control mechanisms, and compliance with pricing and reimbursement guidelines for pharmaceutical products.
  6. Healthcare Compliance and Fraud Prevention: We assist in implementing robust compliance programs, addressing fraud and abuse concerns, and ensuring adherence to anti-bribery, anti-corruption, and anti-kickback laws.
  7. Healthcare Licensing and Accreditation: Our services cover compliance with healthcare licensing requirements and regulations for hospitals, clinics, diagnostic centers, and accreditation processes for healthcare facilities.
  8. Product Liability and Safety: We provide guidance on product liability issues, adverse event reporting, recalls, and liability management related to pharmaceuticals, medical devices, and healthcare products.
  9. Data Protection and Privacy: We help clients comply with data protection laws, patient privacy regulations, electronic health records, and data security measures in the healthcare sector.
  10. Dispute Resolution and Litigation: Our seasoned attorneys represent clients in resolving disputes related to intellectual property infringement, regulatory non-compliance, product liability claims, and contractual disputes through negotiation, mediation, arbitration, or litigation.

At Vidhikrit Legal, we are committed to providing top-notch legal services tailored to the unique needs of the pharmaceutical industry. Our experienced team stands ready to support and protect your business interests.

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