Importing Medicines Into India
 Technology, Forms, Registrations, Guidelines, Rules & Regulations, Status, Study, Report
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Project at a Glance Contents on the CD ROM
  • Importing medicines or drugs which nothing but bringing branded name medicines from outside country to marketing in India through legal registration.
  • The various provisions of the Drugs & Cosmetics Rules, thereby introducing a new provision for
    the registration of the manufacturing premises of foreign drug manufacturer and the individual
    drugs prior to their import into the country.
  • Under the new dispensation, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported.
  • The applications can be
    made by authorized agents of foreign firms in India.
  • The process of receiving import registration can take up to 12 months. Once
    you have import registration for a drug, you can apply for a simple
    import license via Form 8 or Form 8A, which is needed for customs clearance.
  • The validity of registration certificates will be 3 years from the date on which these are issued.
  • PITC Pharma is a subsidiary of the PITC & an affiliate of the National Development Company - PITC- supplies medicines to government hospitals, health centers, prisons, and community pharmacies.
  • According to the Indian pharmaceutical group, medicines produced from their country cost about 15-16 times cheaper than the medicines sold in the Philippines.
  • Medicines have become the latest among Indianimports.
  • When compared to previous year, India imported active Pharma ingredients and drug intermediates worth $4.6 billion ( Rs.25,000 crore).
  • Mostly the Pharma sector imports raw materials like
    chemicals intermediates and active pharmaceuticals
    ingredients (APIs).
  • Import of Drugs  is regulated as per the Foreign Trade Policy of Government of India.
  • Sometimes, India has exported more pharmaceutical products than it imports.
  • The pricing methods for imported bulk drugs were based on the landed cost (inclusive of import & customs duty), which was the maximum permissible selling price.
  • All drugs to be imported require their own import registration.
  • Demand in India is growing
    rapidly, due to rising population, increasing elderly people, though importing medicines is considered set to rise strongly.

Technology

  • Indian pharmaceutical environment.
  • Global Pharmaceutical Trade and Contribution of India.
  • Medical technology industry in India
  • Import of drugs for marketing in India.
  • Pharmaceutical Producers of India.
  • Pharmaceuticals Distribution  in India.
  • To make India the  Global Provider of  Medicines at Reasonable Prices.

Forms

  • Application Form for issue of import certificate for import of drugs.
  • Application form for allotment of quota of drug.
  • Application of issue of registration certification for import of drugs into India.
  • Form of undertaking to accompany an application for an import license.

Registration

  • Drug Registration and Import.
  • Registration and Document Requirements for Import.
  • Registration certificate issued for import of cosmetics into India  under drugs & Cosmetic Rules.
  • Import and Registration for marketing of drugs in India.

Rules & Regulation

  • Regulatory approaches & criteria for approvals of biotech medicines in India.
  • Regulatory system and present scenario of Indian Pharmaceutical industry.
  • Biologics Regulation in India.
  • Drug Regulations in India.
  • Regulatory issues in the Indian Pharmaceutical Industry.
  • Indian Regulations & Guidelines.

Guidance

  • Guidance document on common submission format for import License.
  • Guidelines for import & export of drugs & cosmetics.
  • Guide to Export & Import.
  • Draft Guidance on approval of new drugs.
  • Regulatory requirements for marketing authorityin India.
  • Import/Export Restrictions & Prohibitions.
  • Drug and Cosmetics Act & Rules.

Trends

  • Trends in India's Trade in Pharmaceutical Sector.
  • Prescription Drug Importation.
  • Parallel Imports in Pharmaceuticals.
  • Re-importation in Pharmaceuticals.
  • Trends in Trade Balance of pharmaceutical products.

Import Status

  • Importation of Active Pharmaceutical Ingredient Requirements.
  • Global Pharma looks to India.
  • Indian Pharmaceutical Sector - Current Status
  • India's Pharmaceutical industry on course of globalization.
  • Opportunities for the Indian Pharma industry.
  • Exhausting patent rights in India: Parallel Imports.
  • Medicine Import data & import statistics in India.

Policies

  • Policy Reforms in the Indian Pharmaceutical Sector.
  • National policy on traditional medicine.
  • Drugs Regulatory Reforms & Policy Initiatives.
  • Draft National Pharmaceuticals pricing policy.
  • Price Controls on pharmaceutical products in India.

Study

  • Drug Trafficking In India.
  • China & India as suppliers of affordable medicines to developing countries.
  • Product patents & Access to medicines in India.
  • Monopolies pharmaceutical industry in India.
  • Importing Indian Generic Drugs Following TRIPS.

Report

  • Competition Assessment of Pharmaceutical sector in India.
  • Indian Pharmaceutical Industry-Surging Globally.
  • Iran keen to import essential drugs from India to meet current shortage
  • Intellectual Property rights and access to medicines.
  • Price Negotiation for Patented Drugs.
  • Pharmaceuticals and Biotechnology Industry in India
  • Pharmaceuticals & Cosmetics Export promotion council.
  • Indian Pharmaceutical Association.
  • Indian Pharmaceutical industry-import and investment Regime.

News

  • India Trade News and views.
  • Overview of Pharma Industry - Exports and Imports.
  • Import Drugs for Personal Use.

 

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