India’s Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO) are the main regulatory bodies that are responsible for overseeing pharmaceuticals and medical devices within India. The CDSCO exercises regulatory control over the import of drugs and devices, and approves new medical products and clinical trials. The CDSCO also oversees the Drugs Consultative Committee (DCC), the Drugs Technical Advisory Board (DTAB), and the Central Licensing Approving Authority (CLAA), the body responsible for ensuring medical device compliance.
The Drugs and Cosmetics Act
The manufacturing, importing, sale, and distribution of pharmaceuticals and active pharmaceutical ingredients (APIs) in India are regulated under the Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945. The drug product and the manufacturing site must both be registered before the drug can be imported into the country. For products classified as new drugs, the new drug approval must be obtained as a pre-requisite for submitting the registration and import license application. A new drug is defined as a drug that has not been used in India to any significant extent under the conditions prescribed, recommended, or suggested in the product’s labeling, and has not been recognized as effective and safe by the appropriate licensing authority in India.
Under the Drugs and Cosmetics Act, the regulation of the manufacturing, sale, and distribution of drugs and devices is primarily the concern of state authorities. Central authorities are responsible for approving new drugs, controlling the quality of imported drugs, coordinating the activities of state organizations, and providing expert advice to bring about a uniformity in enforcing the Drugs and Cosmetics Act.
The Medical Devices Rules
Medical devices and in vitro diagnostics (IVDs) in India are regulated under the Medical Device Rules that came into effect in 2018. Medical devices are categorized into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), or Class D (high risk) devices. IVDs are categorized separately using the same class names and risk levels from Class A to Class D.
The Central Licensing Authority is the authoritative body that oversees the importation of all classes of medical devices; the manufacture of Class C and D medical devices; the clinical evaluation and approval of investigational medical devices; and the clinical evaluation and approval of new IVDs. The responsibility of overseeing the manufacture of Class A and B medical devices and the sale, stocking, exhibiting, and distribution of all classes of medical devices is delegated to state licensing authorities.
For more detailed information regarding the requirements and process for registering medical devices and pharmaceuticals in India, please see Medical Device Registration in India and Pharmaceutical and API Product Registration in India.
India Medical Device and Pharmaceutical Regulatory Resources
India Medical Device Regulatory Webcast
The India Medical Device Regulatory Update Webcast provides expert insight into the regulatory pathway for India’s medical device market, covering which types of medical devices must be registered under the latest regulations; new requirements for product registration, labeling, and pricing; best strategies for device renewal; and more. Challenges in the registration process will be highlighted in this informative webcast.
Medical Device and Pharmaceutical Regulatory News from India
Pacific Bridge Medical releases timely news briefs on medical device and pharmaceutical regulatory affairs in Asia every month. Click here to view the latest updates on India’s regulations, including:
- India to Jettison Price Controls For Broader Caps on Trade Margins
- India Expands Regulation of Medical Devices
- IVD Sector Rapidly Growing in India, Providing Opportunities for Both Imports and Manufacturers
- India to Require Warning Display on High Risk Drugs
- India Proposes Local Sourcing Requirements for Medical Devices
- India Releases Draft Rules for Drug Clinical Trials
- New In Vitro Diagnostics Regulations in India
- More Price Caps on Medical Products in India
- India to Release New Code for Medical Device Marketing
- India Cuts Prices on Key Drugs
India Medical Device and Pharmaceutical Publications & Presentations
- Expanding Hospital Markets in Asia Provides Opportunities for MedTech Manufacturers: The Hospital Markets in India and Southeast Asia (Part II)
- Demand for More Drugs in Asia Drives Friendly Environment for Clinical Trials
- 2017 Update on the Diabetes Market in Asia
- Lifestyle and Aging Population Continue to Drive Asian Orthopedic Device Market
- Case Study: Sourcing Medical Supplies in India and Vietnam
- Drug Registration in India Presentation
- Asia Cancer Market Update
- Pollution Chokes Asia, Increases Medtech Opportunities
- Exporting More Internationally? Focus On Asia
- Smooth Business Operation in India is No Easy Task