What is the difference between Dcgi and CDSCO?

What is the difference between Dcgi and CDSCO?

The Drug Controller General of India (DCGI) heads the Central Drugs Standard Control Organization (CDSCO). CDSCO is the central drug authority in India. CDSCO is a national level regulatory body under the Ministry of Health and Family Welfare.

What is CDSCO in pharmacovigilance?

the central drugs standard control organization (cdsco), being the apex regulatory authority for approval of drugs in india, is committed to safeguard and enhance the Public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

What are the different appendices of schedule Y?

Schedule Y is applicable for rules 122A, 122B, 122D, 122DA, 122DAA and 122E of the Drugs and Cosmetics Rules, 1945. Schedule Y had 2 appendixes – Appendix – 1, Appendix 1A.

What is Schedule Z?

Schedule ‘Z’ The draft of Schedule Z as prepared by the sub-committee of Ayurveda, Siddha, Unani Drug Technical Advisory proposed to make clinical trials mandatory for all the patent or proprietary) medicines so as to examine the shelf life of ASU medicines.

Is CDSCO statutory?

CDSCO Is India’s Central Drug Regulator. CDSCO Is A Statutory Agency At The State Level, Reporting To The Ministry Of Health And Family Welfare. It Is Responsible For Approving Licenses For Specific Classes Of Drugs And Has Its Headquarters In New Delhi.

Is FDA approval required in India?

All new food additives are mandatorily required to acquire the FDA approval. In case a manufacturer wants to use any new food additive within his product, he must acquire the appropriate approval by putting the said additive through the required testing under the FDA.

Which ICH guidelines explain Pharmacovigilance?

ICH guidelines for pharmacovigilance reporting of adverse drug reactions in the investigational phase of drug development. The ICH has published a number of documents setting standards for safety, both clinical and pre-clinical. Pre-clinical guidelines have an “S” designation e.g. S1, S2 etc.

What is the main objective of CDSCO?

To Protect and Promote public health in India. Mission: To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

What are the ICH GCP guidelines?

The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.

What is T license in clinical research?

Once approved by DCG(I) and IEC, an applicant can start clinical trial as per Schedule Y. Product imported from other countries require a separate license called ‘T-license’ (Trial License), This license is valid for multiple shipments for one year and issued simultaneously with that of the clinical trial approval.

How many GCP guidelines are there?

This handbook defines fourteen principles of GCP, and provides guid- ance and assistance in the application and implementation of these principles by all parties involved in the clinical research process.

What is a Schedule G drug?

Schedule G: Most of these drugs are hormonal preparations. The drug label must display the text “Caution: It is dangerous to take this preparation except under medical supervision” prominently. Examples of substances under this schedule: Testolactone, Hydroxyurea, Carbutamide, Primidone etc.

What is Schedule P?

Schedule P (Form 1120-F) is used to identify and reconcile the foreign corporation’s directly held partnership interests with the distributive shares of partnership effectively connected income (ECI), or expenses allocable to ECI, and the foreign corporation’s effectively connected outside tax basis in each interest.

What comes under CDSCO?

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring …

What is Indian equivalent of FDA?

The Central Drugs Standard Control Organization
The Central Drugs Standard Control Organization is the Indian regulatory body for pharmaceuticals and medical devices, being the equivalent of the FDA in the US.

What products need FDA approval India?

FDA’s approval for colour additives is necessary for the colour additives used in food, drug, cosmetics and even certain medical devices….Medical Devices:

• simple items, like tongue depressors and bedpans.
• complex technologies, such as heart pacemakers.
• dental devices.
• surgical implants and prosthetics.

What products are regulated by CDSCO explain?

Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.