Important Links

• Procedure for Registration
• SOPs for GMP Certificate.(zip)
• Guidelines / Standard Operating Procedure for Quota Allocation of Controlled Substances
• Guidelines for authorized officers under special SROs for issuance of NOC or approval for import of drugs under the Drugs Act, 1976 and Rules framed thereunder
• Guidelines undertaken for performance of Pharmacovigilance activities
• Documents Required for Approval of Post-Registration Variations
• Check List for Scrutinization of Registration Application / Dossiers
• Check List for Allocation of Quota of Controlled Substances
• Import Policy for Drugs

Form's

• Application Form for Registration of a Drug for Local Manufacture
• Application Form for Registration of an Imported Drug
• Application Form for Renewal of Registration of all Kinds of Drugs
• Statement of Quarterly Production
• Documents Required for Approval of Post-Registration Variations

Check List

• Check List for Scrutinization of Registration Application / Dossiers

Policy

• Policy for Inspection of Manufacturer Abroad (For Imported Drugs) (Dt.Up.05-01-2017)
• Policy Guidelines Regarding Reference Regulatory Authorities for Registration of Drugs (Dt.Up.05-01-2017)

Notifications/ SROs

•  NOTIFICATION-SRO 307(I)/2017 Amendments in the Drugs(Labelling and Packing) Rules,1986
• Import of Active Pharmaceutical Ingredients (APIs) / Drug Substances (Dt.Up.04-04-2017)
• Packaging Materials for Pharmaceutical Preparations (Dt.Up.27-03-2017)
• (Export Facilitation For Pharmaceutical Manufacturers)
• Compliation of Data Relating To Registration of Drugs
• Provisional Draft List of Registered Drugs
• Submission of Differential Fee and Deficiencies for Submitted Registration Dossiers

Minutes of Meeting of Registration Board

• Minutes of 238th meeting of Registration Board
• Minutes of 239th meeting of Registration Board
• Minutes of 240th meeting of Registration Board
• Minutes of 241st meeting of Registration Board
• Minutes of 242nd meeting of Registration Board
• Minutes of 243rd meeting of Registration Board
• Minutes of 244th meeting of Registration Board
• Minutes of 245th meeting of Registration Board
• Minutes of 246th meeting of Registration Board
• Minutes of 247th meeting of Registration Board
• Minutes of 248th meeting of Registration Board
• Minutes of 249th meeting of Registration Board
• Minutes of 250th meeting of Registration Board
• Minutes of 251st meeting of Registration Board
• Minutes of 252nd meeting of Registration Board
• Minutes of 253rd meeting of Registration Board
• Minutes of 254th meeting of Registration Board
• Minutes of 255th meeting of Registration Board
• Minutes of 256th meeting of Registration Board
• Minutes of 257th meeting of Registration Board
• Minutes of 258th meeting of Registration Board
• Minutes of 259th meeting of Registration Board
• Minutes of 260th meeting of Registration Board
• Minutes of 261st meeting of Registration Board
• Minutes of 262nd Meeting of Registration Board
• Minutes of 263rd meeting of Registration Board
• Minutes of 264th Meeting of Registration Board
• Minutes of 265th Meeting of Registration Board
• Minutes of 266th Meeting of Registration Board
• Minutes of 267th Meeting of Registration Board
• Minutes of 268th Meeting of Registration Board
• Minutes of 269th Meeting of Registration Board
• Minutes of 270th Meeting of Registration Board