In India pharmaceuticals are governed by the Drugs & Cosmetics Act and the Rules framed to implement the provisions in the Act. New chemical entities may not be administered to human subjects in a clinical trial without permission from the Drugs Controller General of India (DCGI). Such permission may be obtained by submitting to the DCGI an application for a clinical trial (CTA). A CTA package must include a protocol for the study, a draft of the Informed Consent Document, a list of proposed investigators who have agreed to participate in the study, and background information about the drug in accordance with Schedule Y of the Drugs & Cosmetics Rules. The latter may be submitted in the form of an Investigators' Brochure. It takes approximately 12 weeks to obtain permission for a clinical trial for most investigational drugs. The duration may be longer for drugs with special significance to the healthcare concerns of the country or those that may be considered controversial since these are liable to be referred to the Indian Council of Medical Research for comments. Ethic Committee approval is not a necessary precondition for regulatory permission to conduct a clinical trial provided the applicant submits an undertaking that the study will not be initiated at individual sites without prior EC approval. If clinical supplies are to be imported, a "Test-Import License" must be applied for. This is done using the format provided in Form 12 of the Drugs & Cosmetics Rules. Import and manufacture of clinical trial supplies is governed by Rules 33 & 34 and provisions contained in Part X-A of the rules.
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Imported clinical supplies do not attract any import duties. However, imports must be accompanied by an invoice bearing the value of the goods being imported and by a certificate of analysis attesting to the nature and quality of the products.
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Adverse drug reactions occurring during the course of a clinical trial need to be submitted to the DCGI within 14 days if these are unexpected or serious and causally related or result in death. All other serious adverse events need to be submitted along with periodic progress reports. Compliance with GCP guidelines issued by the CDSCO is recommended although this does not have statutory status at the present time. A report on the status of the study with details of enrollment and safety issues needs to be submitted annually and on completion of the study.
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Registration of new drugs for marketing in India requires submission of data generated on Indian patients. A 100-patient non-comparative open-label study on patients treated for the primary indication is sufficient. For drugs that treat rare conditions, a lower sample size is usually negotiable. Submission of India-specific data culled from one or more multi-country studies is often acceptable as a substitute for an India-specific study. Thus, Indian participation in the global development program can reduce registration timelines and enable an early launch in India. In addition to local data, the NDA must include various other items of information listed in Schedule Y of the Drugs & Cosmetics Rules.
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Importation of commercial supplies requires registration of the overseas manufacturing site. The site where the last manufacturing activity for the product is completed is considered as the location to be registered. Import registration requires the submission of additional documents as listed in the schedules D-I and D-II of the Drugs and Cosmetics Rule, including a plant master file, a drug master file, a CPP and power-of-attorney from the exporting party. Import registration entitles the importer to apply for an import license authorizing unlimited imports.
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Samples of the product from the first commercial consignment imported into the country will usually be sent by the port authorities for testing at the Central Drugs Laboratory before the consignment is cleared for distribution and sale.
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Data from prospective post-marketing surveillance is usually required to be submitted to the CDSCO within 2 years of approval of a product. PMS data is considered a prerequisite for renewal of the import license on expiration of validity 3 years from the date of issue.
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Local manufacture of bulk actives and formulations, including local repackaging, requires a manufacturing license from the state Food and Drugs Administration. The latter must be accompanied with manufacturing information and stability data. For new drugs, an approval from the CDSCO is a prerequisite.
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