INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
Application to Other Regulated Products Please note that the above challenge procedure is only applicable for products falling within the purview of “drug” under Section 3 (b) of the DCA and “medical device” defined under Rule 3 (zb) of the MDR (as the case may be). Therefore, if a regulated product (such as a food item) would fall within the above-provid- ed definitions, the challenge procedures mentioned above would apply accordingly. 1.3 Categories of Pharmaceuticals and Medical Devices Pharmaceuticals Under the DCR framework, pharmaceuticals are regu- lated as: • prescription drugs, which require a doctor’s pre- scription; or • non‑prescription or over‑the‑counter (OTC) drugs. These are further classified in the following sub- groups. Prescription-only medicines • Schedule H covers those medicines that can be sold only on the prescription of a registered medi- cal practitioner and must not be advertised to the public (eg, amoxicillin, used to treat bacterial infec- tions such as respiratory tract infections). • Schedule H1 includes certain critical antibiotics and habit‑forming drugs that require a prescription, mandatory record‑keeping by pharmacists, and stricter monitoring to prevent misuse and antimi- crobial resistance (eg, cefixime, used for typhoid fever and other serious bacterial infections). • Schedule X contains narcotic and psychotropic medicines with high abuse potential, which require a special prescription, duplicate record mainte- nance, and tighter controls on storage and sale (eg, morphine, used for severe pain management, such as in cancer patients). Additionally, Schedule G drugs are those which are not technically strictly prescription-only medicines like Schedule H, but they must be used only under medi- cal supervision. Their labels must display the caution: “It is dangerous to take this preparation except under medical supervision.” Such drugs are supervised-use
Department of Revenue, which is a part of the Min- istry of Finance. It oversees illicit opium cultivation, controls narcotic and psychotropic substances, regulates their import/export, and enforces laws through licensing and investigations. 1.2 Challenging Decisions of Regulatory Bodies CDSCO and SDCOs If any person/organisation wishes to appeal against the order of a CLA or SLA, this may be done before the central government or the state government, respec- tively. Upon filing an appeal, the appellant may then be given an opportunity to present their case, and an order to that effect may be issued. The timelines for filing an appeal are defined under the DCR and the NDCT Rules with respect to pharma- ceuticals, and under the MDR with respect to medical devices, and vary depending on the type of appeal (rejection of application to conduct clinical trial, sus- pension of registration/licence by an authority, etc). Aggrieved parties may also approach the appropriate High Court under writ jurisdiction under apposite facts and circumstances. NPPA Aggrieved parties may file for a review of an NPPA notification/order directly with the DoP within 30 days of the publication thereof (Rule 31 of the DPCO). Alter- natively, the party may also approach the appropriate High Court under writ jurisdiction under apposite facts Both the DTBA and the DCC have an advisory role only; recommendations passed by them do not have any binding effect, so no appeals are provided for under the statutes. Similarly, since the IPC is an auton- omous body with no regulatory, approval or enforce- ment role, no appeals are provided specifically. CBN Grievances are generally considered by the Narcotics Commissioner or Additional/Joint Secretary (Narcot- ics), at first instance. Appeals beyond this lie before the respective High Courts. and circumstances. DTAB, DCC and IPC
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