The India module contains 40 Explanatory Documents written by local experts and based on IDRAC proprietary specifications, covering all topics relevant to pharmaceutical industry activities in India. Within the module, you will find key information on:
What is regulated by the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945, along with all amendments
The types of business licenses and applications required for registration of medicinal products in India
The data required for the approval of clinical trials in India
The step-by-step procedure for the conduct of clinical trials in India
How medicinal products are imported into and exported from India
Fees, pricing, and reimbursement
How Indian guidelines including GMP and GCP are regulated
The Indian pharmacovigilance system
Generics and medical devices applications.
The Reference Texts section within the India module includes the Constitution of India, Acts, Rules, Policies, Guidelines and Notifications from 1940 onwards. All reference texts are in English.
For more information, download our India module factsheet.
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