Pharmaceutical, Healthcare, and Life Science Practice

The healthcare industry in India is a significant contributor to the nation’s economy, experiencing remarkable growth with a compound annual growth rate (CAGR) of 22%.  In recent years, the Indian Government has made significant efforts to establish an interoperable healthcare system, leading to the emergence of ancillary services such as EHR/EMR service providers and healthcare administrative services. These initiatives have opened up new opportunities for growth and expansion in the healthcare industry.

The Indian healthcare sector has witnessed a tremendous surge in opportunities over the past decade, thanks to increased governmental focus. Initiatives like the Ayushman Bharath Digital Health Mission and the Ayushman Bharath Scheme have provided incentives for the industry’s growth. Moreover, the COVID-19 pandemic has spurred the development of new segments within the industry, such as telemedicine and health e-service aggregators.

With the government’s push for digitization and interoperable health data records, electronic health records (EHRs) have become a major focal point for healthcare establishments and the insurance sector. This shift in policy has also led to the integration of blockchain, artificial intelligence (AI), and cloud computing into healthcare management systems. Furthermore, there is a growing exploration of remote diagnostics as a cross-section between healthcare and the medical device industry, enabling accurate diagnostics to be conducted remotely.

With our expertise and commitment to excellence, we are well-positioned to support our clients in navigating the complex legal landscape of the pharmaceutical, healthcare, and life science industries, fostering their growth and success in this thriving sector. Our law firm is committed to delivering comprehensive legal services tailored to meet the distinct needs of clients operating in the Pharmaceutical, Healthcare, and Life Science sectors. With an intricate understanding of these industries’ complexities and the ever-evolving regulatory landscape, we offer expert advice and unwavering support throughout all stages of product development and commercialization.

Stage 1: Legal and Regulatory Assistance for Clinical and Preclinical Research

Navigating the legal and regulatory requirements associated with clinical and preclinical research in the pharmaceutical and life science sectors can be challenging. Our highly skilled team excels in guiding clients through this intricate process. We provide invaluable counsel on compliance with pertinent laws and regulations, assisting in obtaining necessary approvals, managing informed consent procedures, and upholding ethical standards.

Stage 2: Comprehensive Support for Product Launch

During the crucial phase of product launch, our firm extends comprehensive regulatory and contractual support to our clients. We address various crucial aspects, including licensing, interactions with state FDA bodies, trademark registrations and searches, patent opinions and searches, collaboration agreements, licensing agreements, and dossier supply agreements, both domestically and internationally.

Stage 3: Expert Regulatory Advice and Support for Product Liability Cases

In the unfortunate event of product liability cases, our firm offers expert regulatory advice and unwavering support. We guide clients through matters related to the Drugs and Cosmetics Act, including product recall procedures and other compliance concerns. Furthermore, our specialized expertise lies in conducting thorough pharma due diligence to assess potential risks and liabilities.

Post-Marketing Legal Advice

Our firm provides comprehensive legal and regulatory advice tailored to post-marketing activities. We offer guidance on scientific promotion, ethical drug promotion, compliance with advertisement regulations for drugs and magic remedies, and specialized advisory services for Ayurvedic products.

Price Control (DPCO): Our team of seasoned professionals is well-versed in the intricate regulations and policies related to drug pricing and control. We provide expert legal advice and assistance to pharmaceutical companies and healthcare institutions in complying with the Drug Price Control Order (DPCO) and other relevant laws. We offer strategic guidance on pricing strategies, negotiations with regulatory authorities, and representation in disputes related to price control.

Medical Device Regulations: We understand the unique challenges faced by companies operating in the medical device sector. Our team has extensive knowledge of the regulatory frameworks governing medical devices, including registration requirements, quality control standards, labeling and packaging guidelines, and post-market surveillance. We assist clients in obtaining necessary approvals, ensuring compliance with applicable regulations, and handling any legal issues that may arise.

Healthcare Sector Expertise

Within the healthcare sector, we offer invaluable legal counsel and support to Clinical Research Organizations (CROs) in various capacities. Our services encompass advising CROs on operational matters, facilitating contractual arrangements, overseeing data exchange and data services, and ensuring strict compliance with data privacy regulations. Additionally, we extend our legal and regulatory advice to hospitals, assisting them in complying with clinical establishment rules, pharmaceutical regulations, and establishing contractual agreements with diagnostic and pharmaceutical industries.

Hospitals, Diagnostic Labs, and E-pharmacies: Our experienced team of lawyers is well-versed in the legal and regulatory framework governing hospitals, diagnostic labs, and e-pharmacies in India. We provide tailored solutions to address the specific needs and challenges faced by our clients in these sectors. From licensing and regulatory compliance to privacy and data protection, we ensure that our clients are fully informed and compliant with the applicable laws and regulations. Our expertise covers areas such as licensing and accreditation, patient rights, data privacy and protection, and contractual agreements with healthcare professionals. We stay updated with the latest developments in healthcare legislation, including the relevant acts such as the Clinical Establishments (Registration and Regulation) Act, 2010 and the Medical Termination of Pregnancy Act, 1971, among others. Our services encompass licensing and certification, quality control and assurance, laboratory accreditation, data protection, and compliance with the relevant laws, including the Clinical Laboratory Improvement Amendments (CLIA) and the Drugs and Cosmetics Act, 1940. We guide our clients on licensing requirements, online sale and distribution of pharmaceuticals, data protection, advertising and promotional activities, and compliance with the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021.

AI Legal and Regulatory Advice for Healthcare: In an era of rapid technological advancements, the integration of artificial intelligence (AI) in the healthcare industry has presented unique legal and regulatory challenges. Our firm is at the forefront of providing cutting-edge legal advice in this area. We assist healthcare providers, pharmaceutical companies, and life science organizations in navigating the legal implications of AI adoption, including issues related to data privacy, intellectual property, liability, and ethics. Our team stays up-to-date with the latest developments in AI regulations to offer comprehensive and forward-thinking solutions. Our expertise extends to the relevant legislation, including the Information Technology Act, 2000, and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011 to name a few.

In navigating this regulatory landscape, we draw upon our in-depth knowledge of key legislation. We are well-versed in the National Medical Commission Act, Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, Clinical Establishments Act (Registration and Regulation) Act, Telemedicine Practice Guidelines, The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, National Commission for Allied and Healthcare Professions Act, National Commission for Indian System of Medicines Act, National Commission for Homoeopathy Act, Dentists Act, Pharmacy Act, Consumer Protection Act, and Drugs and Cosmetics Act. At our law firm, we recognize the unique challenges and legal requirements faced by the pharmaceutical, healthcare, and life science sectors. Our dedicated team of experts specializes in providing tailored legal services that empower our clients to navigate complex regulatory frameworks, safeguard their interests, and successfully achieve their business objectives.