Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs. Central Drugs Standard Control Organization Head quarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and functions under the Directorate General of Health Services.
New Drugs Approvals
- Manufacturing Approvals of FDCs and Single Molecule New Drugs on Stability Study, Bio-equivalence Study, Clinical Trial Study or Toxicity Study.
- Manufacturing Approval of Bulk Drugs in India.
- Strategy Development for Approval of 1st time FDC.
- Preparation of Rationale & Justification for Fixed Dose Combination (FDC)
- Expediting Expert letters from DCGI to experts.
- Assistance in preparation of Form 44 [read with appendix 1 to Schedule Y] for Clinical trial approvals- Global/ India specific.
Import Registrations of Drugs – Biologicals – Medical Devices – Diagnostics – Blood products
- Registration/Re-Registration of foreign Manufacturing Premises
- Import Registration of individual Formulations, Bulk Drugs, Medical Devices and Cosmetics
- Providing Import License in Form 10
- Test license for the purpose of examination, test or analysis in Form 11.
- Urgent Import of Life Saving Drugs or Import of personal use drugs
- Assistance in Rule 37 [permission to re-pack].
- Certificate of Pharmaceutical Product (COPP)-WHO GMP from Zonal offices.
- Organizing testing of samples at various Central Drug Laboratories.
- Organizing testing of samples at National Institute of Biologicals Noida./li>
Services to Clinical Research Organization (CRO’s)
- Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
- Expert reports on Quality, Pre-clinical and Clinical studies.
- Orphan Drug Application Preparation and Submission.
- Monitoring and liaising with the CRO’s for Clinical and BE Studies
- • Submission of SUSARS & SAE’s on priority basis as per time schedules prescribed by DCGI including correspondence on Compensations issues
Regulatory Submissions
- Preclinical & Clinical Development Plans
- Protocols, Investigator Brochures
Dossier Preparation (For all kind of submissions)
- Prepare dossiers for various applications like Clinical trial approval (Form-45),
- Manufacturing/import permission (Form-45),/li>
- Test license (Form-11),
- Drug Registration certificate (Form-41),
- Import license (Form-10),
- Neutral code, NOCs of different purpose,
- Drug Sales license (Form – 20 B & 21 B),
- CLAA approval, Manufacturing license (Form – 28, 28 A)
- Bioequivalence study approval form 44