Pharmaceutical and Health Care

 

Pharmaceutical and Health care is one of the fastest-growing sectors in India.  It is also one of India’s largest sectors- both in terms of revenue and employment. Health care comprises hospitals, medical devices, clinical trials, outsourcing, and health insurance. As per records, the Indian healthcare market accounts market worth US$100 billion with an expectation that it will grow to US$ 280 billion by 2020. Likewise, the Healthcare industry is the third-largest industry in terms of volume, and India’s healthcare industry accords one of the important positions in the global pharmaceuticals sector. Both the Pharmaceutical and Healthcare industries witness exciting development and research opportunities with changing advances that directly have an impact on life. With this advancement, the requirement of litigation and other legal requirements is also accelerating.

Indian Pharmaceutical industry witnessed a paradigm shift with India becoming a signatory nation to the WTO order. Earlier before Jan-2005 only process patent was granted. But with the advent of the Patents Amendment Act, the 2005 product patent was introduced and has now made India TRIPS compliant.  This has opened an attractive option for various young technology and science experts for the introduction of research-based products. But it again posed problems for the generic industry which no longer continues the production of generics without a license.  India has also marked considerable progress in Stem cell research which has specific guidelines but is yet to be regulated by the governing law which will be made very soon.

The pharmaceutical and Healthcare legal team at Astrea can understand the technicalities engraved in the pharmaceutical and healthcare industry with minute differences. The team deals strategically with a situation to address a unique solution It possesses in-depth knowledge of various legal and regulatory frameworks related to the Healthcare and Pharmaceutical industry.

The team provides legal assistance on the following matters

> Distribution, Manufacturing and Supply Agreements, import and Sponsorship of drugs.

> Product liability defense

>  Licensing

>  Intellectual Property protection and registration such as Patents, Trademarks, and agreements relating to know-how licensing, etc.

> Labelling and packaging guidelines & FSSAI regulations

> Advice and consultancy to Hospitals and World-Class Health Institutions in structuring their businesses

>  Advisory and assistance on tax-related issues.

>  Litigation, Due Diligence, and Structuring of Foreign Investment and related regulatory approvals.