Business Opportunities For Biotechnology In India

Biotechnology and Its Segments

Biotechnology applies living organisms in various industries like agriculture, healthcare, and industry. Key sectors include:

• • Agriculture: Plant breeding, genetic engineering, and improving nutritional values.
  • Healthcare: Vaccines, therapeutics, and drug development.
  • Industry: Use of biological processes in manufacturing.
  • Environment: Bioremediation and waste treatment.

Indian Biotechnology Scenario

India ranks as one of the top 12 biotech destinations globally, second in Asia after China. It’s the world’s largest producer of the Hepatitis B vaccine. The major sectors in India’s biotechnology include:

• • Bio-pharma: 40% (Vaccines and therapeutics)
  • Bio-services: 21%
  • Bio-agriculture: 19%
  • Bio-informatics: 14%
  • Bio-industrial: 5%

Business Opportunities

India offers significant opportunities for foreign companies in biotechnology. Entry options include:

• • Distributor Appointment: Partnering with a distributor for market penetration.
  • Liaison Office: Allowed for market development but not business transactions.
  • Branch Office: Allows technical support and consultancy services.
  • Joint Venture/Wholly Owned Subsidiary: Full operations through incorporation.

Government Initiatives

The Indian government has launched various schemes to foster biotech growth:

• • Small Business Innovation Research Initiative
  • Biotechnology Industrial Partnership Programme
  • Industrial Infrastructure Upgradation Scheme
  • Industrial Park Scheme

Legal and Regulatory Framework

Biotechnology in India is regulated by various laws, including:

• • Environment Protection Act, 1986
  • Drugs & Cosmetic Act, 1940
  • Foreign Exchange Management Act, 1999
  • Intellectual Property Laws
  • Biological Diversity Act
  • Recombinant DNA Safety Guidelines

Authorities

Key regulatory bodies include:

• • Department of Biotechnology (DBT)
  • National Biotechnology Board (NBT)
  • Genetic Engineering Approval Committee (GEAC)
  • Institutional Biosafety Committees (IBSC)
  • Biotechnology Regulation Authority of India (BRAI) (Proposed)

Licenses and Permissions

Agricultural Biotechnology: FDI up to 100% under the automatic route, with certain approvals needed if the company has prior collaborations. Medical Biotechnology: FDI up to 100% but requires approval for certain products involving recombinant DNA technology.

Tax Incentives

Biotech companies can avail:

• • 150% tax deduction for scientific research expenditure.
  • Tax holidays for R&D companies.
  • Concessional sales tax rates in biotech parks.
  • Export Oriented Units (EOUs): Exemptions on duties and indirect taxes for units exporting biotech products.

Recent Case Laws

• • Novartis Case: The Indian government denied a patent for the cancer drug Glivec due to its incremental innovation, citing Section 3(d) of the Indian Patent Act.
  • Kibow Biotech & La Renon Case: The Intellectual Property Appellate Board ruled that simple mixtures of known ingredients do not qualify as inventive and therefore are not patentable under Section 3(e) of the Patent Act.

This provides a snapshot of the biotechnology sector in India and the regulatory landscape. If you require further details or have specific legal questions, the firm Astrea Legal Associates LLP can offer expert consultation.