Drug Manufacturing

The manufacture of allopathic drugs necessitates meticulous adherence to regulatory guidelines to ensure product safety and efficacy. This guideline delineates the procedural intricacies involved in obtaining a manufacturing license for allopathic drugs, providing a comprehensive roadmap for aspiring manufacturers.

Here’s an in-depth look at the documents required and our streamlined timeline for processing:

Timeline: Overall procedure takes about 75 days.

Mode of Application: Online – e-Sevai Open Portal

Documents Required

Covering Letter: A formal communication addressed to the Director of Drugs Control, Chennai, accompanied by a Rs. 2/- court fee stamp for each license.
Application Form: Submission of either Form-24, Form-27, Form-24F, or Form-27B, duly filled and signed by the applicant.
Product Details: List of products with composition (in quadruplicate), including copies of Drugs Controller General (India)’s approvals, if required, specimen label, and therapeutic justification for patent and proprietary medicines.
Method of Manufacture: Comprehensive documentation outlining the method of manufacture of bulk drugs, specification of intermediates, Material Safety Data Sheet of materials used, and specifications/methods of analysis for raw materials and finished products.
Export-Specific Details: Brand name declaration for products manufactured exclusively for export and stability data.
Test Licenses and Laboratory Consent: Submission of Test Licences in Form 29, along with consent letter from an approved laboratory, if applicable.
Applicant Details: Documentation pertaining to the constitution of the concerned firm/company/LLP, list of directors/partners, their biodata, residential addresses, and photos, along with address/ID proof of the applicant.
Technical Personnel Details: List of manufacturing chemists/analytical chemists, along with their biodata, passport-size photos, photocopies of qualification and experience certificates, declaration of manufacturing/analytical chemists, and their address/ID proof.
Premises Details: Submission of ownership documents, premises plan detailing partitions, measurements, and machinery locations, rental agreement if applicable.
Machineries/Equipments: List of machineries, equipments, AHU’s, water systems provided for manufacturing, list of analytical instruments/equipments, and photocopies of purchase invoices with details like production capacity and make.