BP606TSemester 63 creditsTheory
Pharmaceutical Jurisprudence
Complete unit-wise syllabus for BP606T as per the PCI B.Pharm NEP 2020 curriculum (Semester 6 — AI in Pharma + Analysis + Internship II).
URL:
https://pharmacode.in/syllabus/semester-6/bp606t-pharmaceutical-jurisprudence/Unit-wise Syllabus
5 Units1
Drugs and Cosmetics Act 19409 Hours- Historical background and objectives; definitions: drug, cosmetic, patent/proprietary medicine, new drug; schedules to the Act (A through Y and E1, E2, H, H1, X, G)
- Licensing provisions: manufacture, sale, import; designated authorities (Central and State Licensing Authorities); conditions for licence grant; form of licences (21, 20B, 27B)
- Prohibition of manufacture, sale, and import of certain drugs; misbranded, adulterated, spurious drugs; offences and penalties under the Act
2
Pharmacy Act 1948 and State Regulations9 Hours- Pharmacy Act 1948: objectives; constitution and functions of Pharmacy Council of India (PCI); State Pharmacy Councils; Central Register of Pharmacists
- Registration of pharmacists: eligibility, process, renewal; code of professional ethics for registered pharmacists
- Pharmacy education regulations: ER 1991, ER 2014 amendments; Pharm.D regulations; B.Pharm and D.Pharm standards
3
NDPS Act 1985 and Other Drug Laws9 Hours- Narcotic Drugs and Psychotropic Substances (NDPS) Act 1985: definitions; Schedules I and II; licensing for manufacture, possession, sale of narcotic drugs; import/export
- Precursor chemical control; international conventions (Single Convention on Narcotic Drugs 1961, Convention on Psychotropic Substances 1971)
- Medicinal and Toilet Preparations (Excise Duties) Act 1955; Poisons Act 1919; Prevention of Food Adulteration Act and Food Safety and Standards Act (FSSAI)
4
Drug Price Control and Consumer Protection9 Hours- Drug Price Control Order (DPCO) 2013: objectives; scheduled formulations; ceiling price calculation; NPPA's role; impact on pharma industry
- Jan Aushadhi scheme and Pradhan Mantri Bhartiya Janaushadhi Pariyojana; generic medicines and affordability
- Consumer Protection Act and consumer rights in healthcare; product liability; Medical Device Rules 2017; e-pharmacy regulations; Clinical Establishment (Registration and Regulation) Act 2010
5
Recent Developments in Pharmaceutical Law9 Hours- New Drugs and Clinical Trials Rules 2019: new drug definition; CT approval process; ethics committee requirements; accelerated approval pathway; academic clinical trials provisions
- Schedule Y: clinical trial requirements in India; waiver of Phase I and II data for global drugs; CTRI registration mandatory requirement
- Pharmacovigilance regulations: regulatory requirements for post-marketing surveillance; periodic safety update reports (PSURs); risk management plans under Indian law
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What's coming next on this page
- Reference textbooks and recommended reading list
- Previous year question papers (PYQ)
- Topic-wise short notes and revision summaries
- Suggested external resources and video tutorials
Other subjects in Semester 6
BP601TAdvanced PharmacognosyBP602TBiopharmaceutics and PharmacokineticsBP603TIntellectual Property RightsBP604TAI Applications in Pharmaceutical SciencesBP605TPharmaceutical AnalysisBP607T AECAEC Elective (Green Chemistry / Materiovigilance / Scientific Writing / Drug Store Management / Medicinal Plant Cultivation / API Sciences)BP608PBiopharmaceutics and Pharmacokinetics (Practical)BP609PPharmaceutical Analysis (Practical)BP610P SECSEC Elective — CADD / Analytical Method Development / Preclinical Studies (Practical)BP611P VACVAC Elective — Professional Skills / PAT & QbD (Practical)BP612IInternship II (Mandatory)