Pharmaceutical and Health care is one of the fastest growing sectors in India. Its is also one of the India’s largest sector- both in terms of revenue and employment. Health care basically comprises hospitals, medical devices, clinical trials, outsourcing and health insurance. As per records, Indian healthcare market accounts market worth US$100 billion with a expectation that it will grow to US$ 280billion by 2020. Likewise, Healthcare industry is third largest industry in terms of volume and India’s healthcare industry accords one of the important position in the global pharmaceuticals sector. Both Pharmaceutical and Healthcare industry witness exciting development and research opportunities with changing advances which directly have impact on life. With this advancement, requirement of litigation and other legal requirement is also accelerating.
Indian Pharmaceutical industry witnessed a paradigm shift with India becoming a signatory nation to WTO order. Earlier before Jan-2005 only process patent was granted. But with the advent of Patents Amendment Act, 2005 product patent 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 generic industry which no longer continue the production of generics without license. India has also marked considerable progress in the Stem cell research which have specific guidelines but yet to be regulated with the governing law which will be made very soon.
The pharmaceutical and Healthcare legal team at Astrea have the capability to understand the technicalities engraved in pharmaceutical and healthcare industry with minute differences. The team deals strategically to a situation to address a unique solution It posses in-depth knowledge of various legal and regulatory framework related to 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 defence
• Intellectual Property protection and registration such as Patents, Trademarks etc. and agreements relating to licensing of know-how etc.
• Labelling and packaging guidelines & FSSAI regulations
• Advise and consultancy to Hospitals and World Class Health Institutions in structuring their businesses
• Advisory and assistance on tax related issues.
• Litigation and Due Diligence and Structuring of Foreign Investment and related regulatory approvals.