India Regulatory Services

CliniExperts is the catalyst you need to speed up your registration process without worrying about obstacles. Our experience, professional relations understanding and wealth of practical familiarity in the field serve to ease your way through the process. With CliniExperts, you will receive expert advice, 24 hour support, practical guidance and complete technical assistance right from the beginning till the very end of your penetration into the Indian market.

WE AID OUR CLIENTS IN ALL REGULATORY MATTERS

Regulatory bodies are organizations that have the responsibility to scrutinize, steer and manage different sectors in order to ensure the safety of consumers. Such bodies are formulated by the Government in sectors like the drug industry, cosmetic industry and food industry to regulate and control the quality of products that are made accessible to consumers through the market. Brief descriptions of some apex regulatory bodies that govern the Indian markets are:

Cdsco/state fda/zonal cdsco

The Central Drugs Standard Control Organization (CDSCO) is a regulatory body that lays down stringent standards that any drug, medical devices, diagnostic kits, cosmetics, biologicals and vaccines being introduced into the country must meet before being sold in the market.

The State Food and Drug Administration has branches in every state that serve to maintain safety and quality standards of food ingredients, food products and imported drugs. This is the highest governing authority for all food and drug clearances needing entry into the country and every state.
CDSCO has 6 Zonal Offices which are headed by Dy. Drugs Controller (India). These have several responsibilities including Grant or renewal of manufacturing licenses for Vaccine, LVP, Bio-Tech/Biosimilar products, and Medical Devices, Approval of Institution for carrying out Test on Drugs, Cosmetics and Raw materials, Approval BA/BE studies and Clinical Trial site, Grant or revalidation of COPPs, Issuance of COPPs for additional products and any other inspection communicated from the Office of the DCGI.

Fssai

The Food Safety and Standards Authority of India (FSSAI) is a branch of the Ministry of Health and Family Welfare dedicated to standardizing food products made available in the market through a series of stringent standards that ensure food safety. They ensure only the highest quality of foods are made available to the public.

Icmr

The Indian Council of Medical Research (ICMR) essays a vital role in the prevention and control of communicable diseases, research regarding toxicology, immunology, reproduction, national medical statistics, food standards and other primary health topics of national interest. It is the leading body regulating all medical research in the country.

Dsir

The Department of Scientific and Industrial Research (DSIR) is an apex body in India that regulates and standardizes topics concerning scientific and industrial sectors of national importance. It also holds the power to grant recognition to public funded universities and is the controlling power over all the IITs and IISCs.

Dgft

The Directorate General of Foreign Trade(DGFT)is responsible for the regulation of trade, specifically export and import. It plays a pivotal role in granting licenses and authorizing trade transactions between India and other countries. Thus all companies making an entry into India, must go clear it.

Nppa

The National Pharmaceutical Pricing Authority (NPPA) has been set up by the government to control and regulate standardized prices for the drugs available in the Indian market. It ensures that drugs that are needed by masses, and all essential drugs are affordable and easily available throughout the country.

Cibrc

The Central Insecticide Board and Registration Committee(CIBRC) was set up by the Department of Agriculture and Cooperation in order to standardize the quality of insecticides available in the country in order to prevent danger. It ensures that all tenements of the Insecticide Acts and Rules are followed meticulously.

Cbn

Central Bureau of Narcotics (CBN) is affiliated with India’s Department of Revenue (IRS) and regulated by the country’s Central Board of Excise and Customs. The main function of CBN is to stop opium production and trade, and to issue licenses for production of legal synthetic drugs. The Central Bureau of Narcotics headquarters are located at Gwalior.

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Regulation/Guidelines

The Indian Ministry of Consumer Affairs Relaxes Import Norms of Infrared Thermometers

With the spurt in demand for infrared thermometers in India due to Coronavirus pandemic, the Government of India has eased down procedures at the custom level for easier import of the non-contact infrared thermometers by issuing no-objection certificate (NOC) for release of these medical devices.

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Insight

How Legal Metrology Affects the Market of Smart Watches – Part 1

Smart watches are gaining interest of consumers rapidly these days as they serve the standalone purpose and function of many gadgets.   A smart watch is a touchscreen operated wearable computer in the form of a wristwatch. While early models could perform basic tasks, such as calculations, digital time telling, […]

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Regulation/Guidelines

Licensing Process and Rules Related to Phytopharmaceutical Drugs in India

Now when you know about what is a new phytopharmaceutical drug, now you must be thinking about how and from where to obtain permission either for its import or manufacture? For importing or manufacturing a new phytopharmaceutical drug in India, one needs to apply for a license. For obtaining permission […]

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Regulation/Guidelines

CDSCO Announced Clinical Trials Conduct Rules During COVID-19 Outbreak

This guidance document covers the actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority

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Regulation/Guidelines

Regulations for Hand sanitizers and home drug deliveries by CDSCO in India

Regulations regarding hand sanitisers and home deliveries of the drugs, along with the list of approved formulations for hand sanitisers

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Regulation/Guidelines

New Notification on Regulating All Devices – Deciphering the Key Concepts

The Medical Devices Rules (MDR), 2017 came into effect from 1st January, 2018. On February 11, 2020, two major notifications related to the Medical Devices Rules, 2017 were published by the Government of India. The notifications included: A new definition of medical devices. The Medical Devices (Amendment) Rules, 2020 As […]

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Regulation/Guidelines

CDSCO prioritizes Regulatory Approval of In-vitro Diagnostic Kit for COVID-19

World Health Organization (WHO) has declared Corona virus Disease (COVID -19) as a global pandemic. A recent coronavirus outbreak is a public health emergency of international concern due to its rapid transmission and spread. So far, till March 1, 2020 there have been 191,127 confirmed cases, and among them, 7807 […]

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