Medical Device & Diagnostic Industry

ecutive in charge of manufacture should be in place. The names of the competent technical personnel have to be included in Form 27. Certain states require the personnel to be licensed through a locally conducted examination. Additionally, some states require that the plant layout be submitted for formal approval before construction is started.

Inspection

After Form 27 has been submitted, DCGI, SDC, and a technical expert conduct a joint inspection. Usually the first inspection takes a few days to finish, but there is no set time. The qualifications and experience of the manufacturing staff will be verified during this time. Sample batches of product are required and will also be examined. Inspectors could have queries and may ask for remedial action. If so, the plant would be subject to reinspection. The products from the sample batch can be sold later on the market if they are of appropriate quality. The trial runs conducted before a full-fledged manufacturing license is obtained require a separate test-manufacturing license. If items classified as drugs are needed for trial production, the manufacturer must get a wholesale drug license. This allows the device maker to receive and store drugs until a regular manufacturing license is obtained.

Receiving and Maintaining a License

There is no specified time period for receiving a license (Form 28). It could take up to six months after inspection. In part, this could be due to clarifications, correspondence, rectification, and reinspection. If there is no issue with the plant inspection and the documentation submitted with the

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application, the license could be received even earlier. Form 28 is valid for five years from the date of license unless it is revoked, cancelled, or suspended for any reason. Once licensed, the factory is subject to inspection, sampling, and testing of product by the drug control authorities at any time. The license permits the holder to manufacture, stock, and distribute devices from those premises and to stock drugs as raw materials. Distributors and retailers handling the device require sale and stock licenses.

Raw Materials

Raw materials, whether drugs or otherwise, purchased in India do not require a purchase license. However, a registration certificate from DCGI is required specifically for each overseas manufacturer, manufacturing site, and product. This involves detailed dossier submission by the foreign manufacturer. A fee of $1500 for each manufacturing site and $1000 for each product from a site must be paid. Fees of up to $5000 may also be charged for an inspection visit to each foreign site.