INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
Pre‑licensing GMP inspections are mandatory and are conducted by the relevant drug inspectors. Medical Devices For medical devices, just like pharmaceuticals, no separate, standalone plant authorisation is required. However, for a manufacturing or import licence, appli- cants must show that the site operates an accept- able Quality Management System (eg, ISO 13485) and must comply with the MDR. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesale sales, stocking or distribution of pharma- ceuticals and medical devices require a wholesale licence granted by the respective SLA. The licence is issued on application in the prescribed form after the SLA verifies that there are adequate premises, stor- age conditions and competent staff, and it authorises the wholesale stocking and sale of drugs, including medical devices. A wholesale licence under the DCR also permits the stocking and sale of medical devices, while entities dealing only in medical devices may instead obtain a registration certificate under the MDR, with fewer premises requirements. The wholesale licence is valid in perpetuity, subject to the payment of a retention fee every five years, failing which the licence is deemed cancelled. 6.2 Different Classifications Applicable to Pharmaceuticals As detailed in 1.3 Categories of Pharmaceuticals and Medical Devices , the DCR sets the following clas- sifications: • Schedule H are prescription‑only medicines; • Schedule H1 consists of drugs that have a high risk of misuse, but does not include narcotic or psy- chotropic drugs; • Schedule X consists of narcotic or psychotropic drugs that have a very high potential for misuse;
• Schedule G drugs are usually taken under medical supervision only; and • OTC drugs are non-scheduled or non-prescribed drugs that are not covered under Schedule H, H1 or X. Certain products exempted under Schedule K may also be sold without a prescription, subject to the spe- cific conditions laid down therein. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies DCA and DCR The DCA and DCR regulate the import of drugs into India and require importers to obtain a registration certificate and an import licence. The import of medi- cal devices is regulated under the DCA read with the MDR, and requires an import licence, while exports of drugs and devices do not require licences under this framework. Furthermore, the CLA grants import licences for drugs and medical devices. It reviews applications to ensure compliance with statutory, safety and quality requirements before permitting import. Foreign Trade (Development and Regulation) Act, 1992 (FDTR Act) The FTDR Act governs the trade control aspects of importing and exporting pharmaceuticals and medi- cal devices in India. Under this Act, the Director Gen- eral of Foreign Trade (DGFT) regulates such products through the Foreign Trade Policy and ITC (HS) clas- sification, requiring licences or authorisations where drugs or devices are restricted or prohibited. Customs authorities enforce these controls at ports of entry and exit, while the DGFT oversees post‑trade compliance and penalties. Customs Act, 1962 The Customs Act regulates customs clearance pro- cedures at ports of import and export. Importers and exporters must accurately declare goods, ensure cor- rect classification and valuation, pay applicable duties, and submit prescribed documents such as Bills of Entry
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