India
Regulatory Services

Regulatory Solution Provider for Indian Market

india-regulatory

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

Principles for Safety & Performance of Medical Devices

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, […]

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Draft Guidelines on Similar Biologics, 2016

Medicinal products which are mainly composed of living tissues or cells are called Biologics

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Medical Devices Rules, 2016: An Overview

CDSCO issued a draft of Medical Devices Rules, 2016 through a gazette notification (No. 724) published on October 17, 2016

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India Champions e-Governance for Pharma Industry

National e-Governance plan (NeGP), launched in 2006 as initiative that Government of India has implemented to make all government services accessible online.

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Kokate Committee

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, […]

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MEDICAL DEVICE REGISTRATION IN INDIA

Medical device industry is still nascent in India, most devices are manufactured globally and imported

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Self-Assessment/Audit of Unit for GMP/GLP Compliance

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, […]

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New Medical Device Rules To Be Rolled Out In 2018

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, […]

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FSSAI Regulations for Caffeinated Beverages

FSSAI has added standards for caffeinated beverages and use of blue tint in the plastic bottles related to beverages non-alcoholic carbonated food products

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