Pharmaceutical and API Product Registration in India

Pharmaceutical and API Product Registration in IndiaForeign pharmaceutical companies nowadays have a better legal foundation (patents) for releasing new drugs in India. General policies toward foreign investment have also improved significantly. The timing of these structural changes coincide with India’s growing demand for newer classes of drugs as well as their increasing ability to afford international prices. Although recently developed foreign drugs are now increasingly able to take advantage of India’s drug demand growth, the Indian medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing.

Pacific Bridge Medical’s pharma consultants have years of experience with developing and implementing effective regulatory strategies that comply with India’s regulations. You can count on our expert consultants for assistance with the efficient and timely registration of your pharmaceutical or API product in India.

To read more details about the drug registration process in India, click on the following questions.

Which regulatory bodies in the Indian government are responsible for pharmaceutical product registration in India?

The main national pharmaceutical oversight agency is the Central Drugs Standard Control Organization (CDSCO).  The CDSCO is commonly referred to by the title of its head official, the Drugs Controller General India (DCGI).

Do pharmaceutical products in India require registration?

Yes, all pharmaceuticals imported into India must have prior approval from the DCGI.

What does the registration pathway look like for pharmaceutical products?

Obtaining approval for the import of drugs into India consists of up to three main phases:

  1. New drug approval – the product must go through an approval process to obtain a drug registration (this regulation is dependent upon the type of pharmaceutical and whether a predicate drug or substance is already marketed in India, is not necessarily only for new drugs, and must be received from the DCGI).
  2. Import registration certificate – This registration is only required for drugs to be imported, not manufactured. It should also not be confused with the import license, which actually lets a shipment pass through customs. Import registrations are submitted to the DCGI, the applicant for an import registration certificate cannot simply be an Indian agent or consultant to the manufacturer. It must be an entity, which is licensed to either sell wholesale or manufacture drugs.
    • Since import registration is attached to the drug’s actual manufacturing site, the DCGI reserves the right to inspect the site if necessary. In these cases, the site is evaluated against Indian Good Manufacturing Practice (GMP), however, the DCGI will usually trust GMP certification from an advanced country such as the US or Europe. Inspections are more likely for drugs produced in other low-cost countries such as China.
    • The India Drugs and Cosmetics Act (DCA) states that the government will generally issue an import registration certificate within 9 months of application. However, the process has been known to go on for longer than this, with further requests for clarification or information.
  3. Import license – The final step for a foreign company to bring a drug into India is to receive an import license. Import license application forms can differ depending on the type and purpose of the drug. At the border, the import license is the only regulatory permission needed to bring in shipments besides general customs requirements. Officials may conduct testing to verify that a shipment’s contents and quality adhere to the license terms. Because of this requirement, drugs may only enter India via cities with appropriate testing facilities. They may enter by sea through Chennai, Kolkata, Mumbai, Kochi, Nhava Sheva, or Kandla, or by air through Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, or Hyderabad.

In India, which drug categories must adhere to the application process for “new” drug approval?

Under Indian law, many products, which are not “new” by Western standards, may still have to go through the new drug application process. The categories that require new drug registration are:

  • Category A – A drug that has not been marketed in India before.
  • Category B – A drug with a new therapeutic purpose or dosage that has not been marketed in India.
  • Category C – A new fixed-dose combination of two or more drugs, if they have not been approved in such a combination before.
  • Category D – A drug or formulation which received its first new drug approval (of any of the types listed above) less than four years ago. This does not apply if the drug has been included in the Indian Pharmacopoeia since then.
  • Category E – Any vaccine, unless certified otherwise by the DCGI.

What documents are required for pharmaceutical registration?

New drug application content varies based on the category of new drug. For any category, all new drug applications must have the following information:

  1. Drug name
  2. Dosage form
  3. Composition of formulation
  4. Test specifications for Active ingredients & Inactive ingredients
  5. Pharmacological classification
  6. Indications
  7. Manufacturer(s) of raw materials
  8. Applicable patents, if any

Are local clinical trials required for registration?

The DCGI typically requires phase III trials to be performed in India before it will approve a foreign new drug for marketing. Other phases may be performed outside India. However, this only applies fully to Category A drugs (“true” new drugs).

Does India have a Drug Master File (DMF) system for APIs?

Yes, the Indian government has a DMF system that allows foreign drug manufacturers to register their key information regarding the quality standards and manufacturing methods of their APIs directly to the DCGI. Registering with the DMF system protects companies’ intellectual property.

Contact us today to discuss your needs with our India pharmaceutical consultants.

Need more information?

Visit our Resource Center to view free webcasts and charts or read publications, news, and research reports on the Asia medical markets.