Snehita Shukla

Strict procedures must be followed in accordance with the rules and guidelines established by the Central Drug Standard Control Organization (CDSCO) when manufacturing medical devices. Additionally, candidates must go through a process by submitting an application for a licence to sell or distribute medical devices if they want to manufacture Class A or Class B medical […]

All models & brands of automotive vehicles-Pneumatic tyres for two & three-wheeled motor vehicles are required to obtain ISI Certification, before their launch or import into the Indian market. BIS ISI for Automotive Tubes & Tyres will only be provided to product manufacturers (whether Indian or foreign) and not to traders, dealers, or distributors. Bureau […]

All Oil-Pressure Stoves with Offset Burners have been added to the Mandatory ISI Certification Scheme under IS Standard-IS 10109. This item cannot be exported or imported or sold on the Indian consumer market unless it bears the ISI Mark. Bureau of Indian Standards grants BIS Certification / ISI Mark (BIS). ISI certification is renowned for […]

The Central Drugs Standard Control Organization (CDSCO) is India’s national body for regulating medical devices and drugs. It performs duties comparable to those of the European Medicines Agency, Food and Drug Administration of the U. S., and the treatments and health services products Regulatory Agency of the United Kingdom. According to the Indian regulatory body, […]

Medical equipment has traditionally been largely unregulated in India. That has transformed recently. Medical Devices Rules 2017 have become effective as of January 1st, 2018, according to Ministry of Health and Family Welfare Notification No. G.S.R, 78(E) dated January 31, 2017. There has been different regulations for notified and non-notified medical devices. In this write-up, […]

The term “cosmetic” is defined in section 3(aaa) of the Drugs and Cosmetics Act of 1940[1]. It states that “cosmetic” includes any item intended to be used as a cosmetic ingredient as well as any object meant to be rubbed, poured, sprinkled, sprayed, applied to the human body or any part for cleansing, beautifying, promoting […]

Indian industrial products have carried the ISI mark since 1955 as a sign of their adherence to national standards. Products bearing this mark are guaranteed to be in compliance with an Indian Standard (IS) created by India’s Bureau of Indian Standards (BIS). Throughout the Indian subcontinent, people know and trust the ISI mark as the […]

In India, the Bureau of Indian Standards (BIS), is the national body for standardisation. BIS oversees standardisation activities as well as quality marking, quality assurance, and product certification, and other matters pertaining to these activities. Indian Standards Institute, also known as ISI, is a body entrusted with establishing the standards necessary for orderly business growth and […]

The CDSCO is the National Regulatory Authority (NRA) of India, which works under the Directorate General of Health Services (DGHS)[1], Ministry of Health & Family Welfare, Government of India. CDSCO, a body that works under the Drugs and Cosmetics Act, is accountable for the approving of drugs and laying down the standard for drugs, to […]