MPY203PMRA: Drug Regulatory Affairs-I (Indian Legislation) Syllabus

MPY203PMRA: Drug Regulatory Affairs-I (Indian Legislation)

The Drugs and Cosmetics act: Drug & Cosmetic Act : 1940 and Rules with emphasis on Good laboratory practices and requirements of premises and equipments (Schedule L-I), Good manufacturing practices for pharmaceutical products (Schedule M), Drugs (Prices Control) Order 1995, Factory Act, Labor Act, The drug and Magic remedies (Objectionable advertisements) act and rules, 1954.

Product Registration : Requirements for registration of pharmaceutical products into India. Preparation of dossier for product registration as per Indian legislative requirements.

Documentation: Master formula record (MFR), Master formula card (MFC), Batch processing record (BPR), Packaging records, Standard operating procedure (SOP), Site master file, specifications, Certificate of analysis (COA), Material safety data sheet (MSDS), Method of Analysis (MOA), Annual product review, validation protocols, Stability protocol, T- License, forms, maintenance of records in Pharmaceutical industry.

Regulatory requirements: and guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials (schedule Y).

Intellectual property rights: Patent, copyrights, design and trademark. Effect of GATT and WTO on commerce of pharmaceuticals. Importance of patent, Application, processing of patent, Indian Patent Act 1970 and its latest amendments, United state patent, world patent processing. Patent term extension.

Practicals Related to Drug Regulatory Affairs-I (Indian Legislation)

1. Preparation of SOP’s for operation of manufacturing and analytical equipments.

2. Preparation of MFR, BPR and packaging record for manufacturing of various dosage forms.

3. Validation of mfg. process, equipment, analytical method, disinfectant, and cleaning process.

4. Process validation for various dosage forms.

Books and References Recommended:

1. Vijay Malik, Law relating to Drugs & Cosmetics.

2. The Gazettes of India. The Drug and Cosmetics Act and Rules and its Latest amendments.

3. The Gazettes of India. The Patent Act 1970 and its Latest amendments.

4. www.patentoffice.nic.in

5. www.ep.espace.net

6. www.uspto.gov