new drug approval from DCI, Customs - Exim - SEZ

[sonu parsad]

Dear All,

Kindly let me know the procedure to get new drug approval from DCI

What are the documents require for the same. How much time will be taken by DCI

or Any other information

Pls advise.

regards,

Sonu Parsad

Posts / Replies

[Seetharaman K C]

 

The Drug and Cosmetic Act 1940 and Rules 1945 were passed by the India's parliament to regulate the import, manufacture, distribution and sale of drugs and cosmetics. The Central Drugs Standard Control Organization (CDSCO), and the office of its leader, the Drugs Controller General (India) [DCGI] was established. In 1988, the Indian government added Schedule Y to the Drug and Cosmetics Rules 1945. Schedule Y provides the guidelines and requirements for clinical trials, which was further revised in 2005 to bring it at par with internationally accepted procedure. The changes includes, establishing definitions for Phase I–IV trials and clear responsibilities for investigators and sponsors. The clinical trials were further divided into two categories in 2006. In one category (category A) clinical trials can be conducted in other markets with competent and mature regulatory systems whereas the remaining ones fall in to another category (category B) Other than A. Clinical trials of category A (approved in the U.S., Britain, Switzerland, Australia, Canada, Germany, South Africa, Japan and European Union) are eligible for fast tracking in India, and are likely to be approved within eight weeks. The clinical trials of category B are under more scrutiny, and approvals are likely within 16 to 18 weeks.

An application to conduct clinical trials in India should be submitted along with the data of chemistry, manufacturing, control and animal studies to DCGI. The date regarding the trial protocol, investigator's brochures, and informed consent documents should also be attached. A copy of the application must be submitted to the ethical committee and the clinical trials are conducted only after approval of DCGI and ethical committee. To determine the maximum tolerated dose in humans, adverse reactions, etc. on healthy human volunteers, Phase I clinical trials are conducted. The therapeutic uses and effective dose ranges are determined in Phase II trials in 10-12 patients at each dose level. The confirmatory trials (Phase III) are conducted to generate data regarding the efficacy and safety of the drug in ~ 100 patients (in 3-4 centers) to confirm efficacy and safety claims. Phase III trials should be conducted on a minimum of 500 patients spread across 10-15 centers, If the new drug substance is not marketed in any other country. The new drug registration (using form # 44 along with full pre-clinical and clinical testing information) is applied after the completion of clinical trials. The comprehensive information on the marketing status of the drug in other countries is also required other than the information on safety and efficacy. The information regarding the prescription, samples and testing protocols, product monograph, labels, and cartons must also be submitted. The application can be reviewed in a range of about 12-18 months.After the NDA approval, when a company is allowed to distribute and market the product, it is considered to be in Phase IV trials, in which new uses or new populations, long-term effects, etc. are explored.