India’s Central Drugs Standard Control Organization (CDSCO)

1. Overview

The Central Drugs Standard Control Organization (CDSCO) functions as India’s primary regulatory authority overseeing pharmaceuticals, medical devices, and cosmetics. The CDSCO is also responsible for supervising the Drugs Consultative Committee (DCC), the Drugs Technical Advisory Board (DTAB), and the Central Licensing Approving Authority (CLAA), which is tasked with ensuring compliance with medical device regulations.

2. CDSCO medical device registration

In India, medical device categorization consists of four classes – A, B, C, and D – organized in increasing order of risk. Devices with low risk include items such as thermometers, while those with high risk include pacemakers, heart valves, and similar items. Furthermore, devices are categorized as either surgical or non-surgical depending on their level of invasiveness.

Indian regulations mandate that a foreign company must engage the services of an authorized licensing agent for medical device registration in India. The regulations explicitly prohibit foreign manufacturers from directly applying for a medical device license from the CDSCO unless they have their own office in India. Alternatively, the foreign manufacturer can designate their Indian medical device distributor as their authorized representative. The Local Representative has to establish an account on the CDSCO’s online portal called SUGAM. Up until about 2017, you could use an independent third party to act as your local representative and register your device in your own name. However, independent third-party registration is no longer allowed.

Starting October 1, 2023, it is obligatory for all importers of Class A (Measuring and Sterile), B, C, and D medical devices to hold an MD-14/15 Import License. The MD-14 application procedure requires the submission of a detailed Device Master File (DMF) specific to each product and a Plant Master File (PMF) outlining the manufacturing facility details. Upon successful completion of a rigorous approval process, an MD-15 Import License including a comprehensive list of all approved medical devices will be issued.

It usually takes 6 to 9 months for an import license to be issued. Products with regulatory approval from reference countries may be approved faster. The license is valid for 5 years and needs to be renewed before expiration.

3. CDSCO pharmaceutical registration

For drug registration in India, the drug classifications include:

• Category A – Drugs not previously available in the Indian market.
• Category B – Drugs featuring a new therapeutic purpose or dosage, not previously marketed in India.
• Category C – Novel fixed-dose combinations of two or more drugs, provided they have not received prior approval in that specific combination.
• Category D – Drugs or formulations that obtained their initial new drug approval (of any types mentioned above) within the last four years, except those included in the Indian Pharmacopoeia during that period.
• Category E – Any vaccine, unless certified differently by the DCGI.

Similar to medical device registration, the local representative in India will have to submit an application via the online portal SUGAM. The content of a new drug application differs depending on the specific category of the new drug. However, regardless of the category, every new drug application is required to include the following details:

• Name of the drug
• Dosage form
• Formulation composition
• Test specifications for both active and inactive ingredients
• Pharmacological classification
• Indications for use
• Information about the manufacturer(s) of raw materials
• Any applicable patents, if they exist

Typically, the Import Registration Certificate takes approximately nine months to be processed from the date of application.