Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

License Application in India with Special Regard to Vaccines

Beate Menkel (Abschlußjahr: 2008)

Marketing Authorisation Application in India is based on the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 as amended. It is required to apply for a marketing authorisation in India for allopathic drugs or modern drugs, Ayuverdic, Siddha and Unani Drugs, Cosmetics and Homoeopathic medicines. Ayuverdic, Siddha and Unani Drugs are traditional Indian medications.

The thesis provides a general overview of the Drugs and Cosmetics Act and Rules. The requirements for the different types of licence application in India and the processes to be followed are described with special regard to vaccines for each type of license specifically and in general.

The process of gaining a marketing authorisation in India is quite complex and differing depending on the legal status and the country of origin of the requesting company and depending on the kind of drug to be licensed. For every new drug in India it has to be applied for a New Drug License. Clinical trials performed in India are needed for a new drug application for a local as well as for a foreign manufacturer. Beside every local company which intends to manufacture and sell a medicinal product in India has to apply for a Manufacturing License.

Every company not located in India which intends to sell or manufacture drugs in or for the Indian market, needs to request for a Registration Certificate and an Import License. The requirements to apply for a Registration Certificate are high. Very detailed information on the medicinal product to be imported has to be provided. In addition a Certificate of Pharmaceutical Product from the country of origin is requested. The Registration Certificate is the pre-requisite for the Import License. To apply for these two licenses a wholesaler with a License for Sale of Drugs in India is required.

It is more difficult to sell a drug in India as a manufacturer not located in India. There are a number of additional requirements and additional licenses needed. The overall process is very time consuming. The most cost and time intensive part is the execution of local clinical trials in India. A manufacturer not located in India has to conduct clinical trials in India regardless of other clinical data already available.

With regard to biologics and special regard to vaccines a quite high amount of specific regulations has been established within the Indian drug law. It lists special requirements for biologics and some very detailed requirements for several vaccines, comparable with pharmacopoeial requirements. Also the requirements for clinical trials list some specifics for vaccines.

License application is a highly regulated procedure within the Indian drug law. The respective rules and forms, give very detailed advice about the license application requirements. It is a great advantage to have a high number of necessary regulations within one compendium. For license application purposes all necessary forms are included in the law. For the regulatory work it is an advantage that the law includes timelines for the review periods of the authority, as long as they are followed. What is still missing from the European perspective is the reference to the ICH-CTD-dossier requirements to get harmonization there.

For the global strategy of an international company it has to be taken into account that there are fundamenta l differences within the law with regard to license application requirements for a local manufacturer and for a manufacturer from a foreign country. There are several advantages for a local manufacturer to bring a medicinal product on the market in India in comparison to a foreign manufacturer. This is also the case for generic drugs. For a new drug the differences are increased e.g. by the request for local clinical trials. There are advantages also during the maintenance of licenses as e.g. it has to be applied for renewals more often by a foreign manufacturer.

For vaccines the regulatory requirements are overall higher than for chemical entities. Manufacturing as well as import of vaccines cause a quite high level of licensing activities in India.

Pages: 57; Annexes: pages: 25