Lawyers

  • Manish Modak

    Partner

    BA. LL.B

    manishmodak@astrealegal.com

    Expertise IT, Retail,Due Diligence, Licence and Registration, Transaction, Asset Management, FDI, Risk, Assessment, Election Laws, Corruption and Bribery Laws, Adoption, Legal Strategy

  • Pradeep Rihal

    Associate

    B.Com. LL.B, LL.M.

    psrihal@astrealegal.com

    Expertise Legal Due Diligence, Work Permits, Credit, Risk Assesment, Security Fraud, Debt recovery, Defamation, Election Laws, Tribunals, Land Laws, Administrative Laws, Insurance, Work Permits, Extradition & Asylum, Forest laws, Corruption and Bribery Laws, Perjury.

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Pharmaceutical and Health care is one of the fastest-growing sectors in India.  Its is also one of 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, the Indian healthcare market accounts market worth US$100 billion with an expectation that it will grow to US$ 280billion 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 industry 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 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 the Patents Amendment Act, the 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 the generic industry which no longer continue the production of generics without a license.  India has also marked considerable progress in Stem cell research which has 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 the pharmaceutical and healthcare industry with minute differences. The team deals strategically with a situation to address a unique solution It posses 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 etc. and agreements relating to licensing of know-how 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 and Due Diligence and Structuring of Foreign Investment and related regulatory approvals.