Approval From Drugs Controller General India

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 Organisations 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 such as blood and blood products, I. V. Fluids, Vaccine and Sera.

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

• 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 and 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.

• 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
• Getting Export Permissions for the export of Bulk drugs and Formulations.
• Certificate of Pharmaceutical Product (COPP)-WHO GMP from Zonal offices.
• Assistance in Rule 37 [permission to re-pack].
• Organizing testing of samples at various Central Drug Laboratories.
• Organizing testing of samples at National Institute of Biologicals Noida.

In order to legally register, import and market, sell your medical products in India you need to be compliant to Indian regulations and legislation. When a company does not have a registered and physical office with statutory personnel and required licenses in India, a legal India Authorized Representative / Agent with the above needs is to be formally appointed. This Authorized Representative will also be held responsible for pre-certification and post-market surveillance inquiries.

• NKC will represent the Client’s organization as the official Indian Authorized Representative / Agent in accordance with India applicable regulatory legislation: The Drugs and Cosmetics Act and Rules.
• Only one Indian Authorized Representative office is needed for the whole country. NKC will represent the Client legally in India without any commercial conflict of interest activities like product distribution, product marketing, product sales etc.
• We will pursue the application assessment and notify when the Registration is accepted.