INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Pharmaceuticals Anyone importing drugs (finished formulations or active pharmaceutical ingredients) must hold a val- id CDSCO import licence (Form 10 and Form 10A, issued after Registration under Form 41 under the DCR) issued via the SUGAM portal. Without it, ship- ments will be detained at customs. Exemptions Personal use exemption (small quantities) (applied under Form 12A) India allows individuals to import smaller quantities of drugs for one’s own individual use under certain conditions. This is typically meant for patients import- ing medicines that are not available in India and is an exemption for drugs, not for higher risk medical devices. Some low‑risk devices may still be brought in personal baggage when not intended for commercial use, but this is examined on a case‑specific basis by customs and CDSCO. Emergency or compassionate use (including COVID‑19 situations) India temporarily issued guidelines permitting the emergency importation of certain products without the usual full registration process – eg, COVID‑19 vaccines approved by major regulators. Medical Devices All medical devices require a CDSCO import licence under the MDR (Forms MD-14 and MD-15 of the MDR). The approval is based on risk classification (Class A–D), device master file, conformity with GCP/ GMP, and the appointment of an Indian Authorised Agent. There is no formal exemption, except discretionary leniency for low‑risk non‑commercial items. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The import of drugs and medical devices into India is controlled by strict regulatory rules. Every product is classified using an Indian Trade Classification (Harmo- nised System) Code, issued by the DGFT, under the
and Shipping Bills. The Central Board of Indirect Taxes and Customs administers customs laws and enforces import and export controls at ports, to facilitate trade and prevent smuggling and duty evasion. NDPS Act This Act applies where the imported or exported prod- uct contains narcotic drugs, psychotropic substanc- es or controlled precursors. It mandates additional licences and authorisations to prevent misuse, diver- sion and illegal trafficking. Under this Act, the CBN regulates the import and export of narcotic drugs, psychotropic substances and controlled precursors. It issues specific authorisations and monitors compli- India regulates imported medical devices under the MDR and CDSCO guidelines. Foreign manufacturers cannot apply directly; they must appoint an Author- ised Indian Agent who meets MDR eligibility (including appropriate wholesale licensing) and shares respon- sibility for compliance, vigilance/recall and corre- spondence with CDSCO. The MDR uses a risk‑based classification and ensures device quality, safety and effectiveness before market entry, to avoid customs delays and enforcement actions. A CDSCO import licence is required to legally introduce medical devices into India. 7.2 Importer of Record of Pharmaceuticals and Medical Devices ance under the NDPS Act framework. The MDR and CDSCO Guidelines A foreign manufacturer must obtain an import licence through an agent authorised in India, who acts as the importer of record for drugs or medical devices in India and would be responsible for regulatory compliance and the liabilities of the foreign manufacturer in India. For pharmaceuticals and medical devices, the Import- er of Record (Agent in India) must be an entity that: • holds a valid licence to either manufacture or sell wholesale drugs under the DCA and the DCR; • is authorised to import drugs into India; and • holds a valid Power of Attorney, which must be duly executed and authenticated either in India before a First-Class Magistrate or before any other equivalent authority in the country of origin.
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