This comprehensive Masterclass module is meticulously designed for the UPSC Drug Inspector Examination 2026, offering a zero-loss protocol for pharmaceutical jurisprudence. It provides an exhaustive categorized reference of all critical application and license forms, procedural timelines, specific offences, and exemptions under various Acts, including D&C, Pharmacy, NDPS, and Clinical Trials, augmented with essential definitions, authorities, schedules, case laws, and exam strategies for complete mastery.
UPSC DRUG INSPECTOR EXAMINATION 2026
MASTER TABLE – ALL FORMS & APPLICATIONS
Complete Categorized Reference – Focus on Memorization
| Category | Application Form | License Form | Key Point |
|---|
| Drugs (General) | Form 19 | Form 25 | Allopathic medicines |
| Biologicals (C, C1) | Form 19C | Form 26 | Vaccines, Sera, Blood products |
| Narcotics (Schedule X) | Form 21 | Form 26A | Psychotropic substances |
| Cosmetics | Form 19A | Form 25B | Beauty products |
| ASU (Ayurveda) | Form 19B | Form 25A | Traditional medicine |
| Medical Devices | Form 27 | Form 26B | Instruments |
| Homeopathy | Form 31 | Form 26C | Homeopathic medicines |
Memory Trick: 19-Series = Apply | 25-Series = Get License
TABLE 2: DRUGS & COSMETICS ACT – SALE (Apply → Get)
| Category | Application Form | License Form | Storage |
|---|
| Retail (General) | Form 20 | Form 28 | Normal |
| Retail (Restricted/Rural) | Form 20A | Form 28A | No pharmacist |
| Wholesale (General) | Form 20B | Form 28B | Normal |
| Retail (ASU) | Form 20C | Form 28C | Ayurvedic |
| Wholesale (ASU) | Form 20D | Form 28D | Ayurvedic |
| Retail (Narcotic X) | Form 20E | Form 28E | Safe/Cupboard |
| Wholesale (Narcotic X) | Form 20F | Form 28F | Safe/Cupboard |
Memory Trick: 20-Series = Apply | 28-Series = Get License | E/F = Narcotics
TABLE 3: DRUGS & COSMETICS ACT – ANALYSIS & LEGAL
| Form No | Purpose | Stage | Used By |
|---|
| Form 8 | Certificate of Analysis | Final Report | Government Analyst |
| Form 9 | Memorandum to Analyst | Sending Sample | Drug Inspector |
| Form 10 | Report of Analyst | Test Results | Government Analyst |
| Form 13 | Receipt for Seized Drugs | Seizure | Drug Inspector |
| Form 14 | List of Seized Drugs | Seizure | Drug Inspector |
| Form 15 | Order for Destruction | Disposal | Court |
Memory Chain: 9 → 10 → 8 (Send → Test → Certify) | 13-14-15 (Seize → List → Destroy)
TABLE 4: DRUGS & COSMETICS ACT – SPECIAL LICENSES
| Form No | Purpose | Category |
|---|
| Form 33 | Certificate of Registration | Blood Bank |
| Form 34 | Blood Bank License | Blood Bank |
| Form 35 | Application for Blood Bank | Blood Bank |
| Form 37 | Blood Storage Centre License | Blood Storage |
| Form 29 | Application for Drug Testing Lab | Laboratory |
| Form 30 | Drug Testing Lab Approval | Laboratory |
TABLE 5: PHARMACY ACT – REGISTRATION (Apply → Get)
| Form No | Purpose | Stage |
|---|
| Form 1 | Application for Registration | Initial |
| Form 2 | Certificate of Registration | Initial |
| Form 3 | Application for Renewal | Renewal |
| Form 4 | Certificate of Renewal | Renewal |
| Form 5 | Application for Duplicate | Lost |
| Form 6 | Duplicate Certificate | Lost |
| Form 15 | Pharmacy Registration (Premises) | Shop |
| Form 16 | Certificate of Pharmacy | Shop |
Memory Chain: 1-2-3-4 (Apply → Get → Renew → Continue) | 5-6 (Lost → Replace) | 15-16 (Shop)
TABLE 6: NDPS ACT – NARCOTICS (Odd = Apply, Even = Get)
| Operation | Application | License/Permit | Special Condition |
|---|
| Manufacture | Form 1 | Form 2 | Government Factory |
| Sale (Retail) | Form 3 | Form 4 | RMP Prescription |
| Import/Export | Form 5 | Form 6 | Ministry Permission |
| Opium Cultivation | Form 11 | Form 12 | MP, UP, Rajasthan only |
| Cannabis Cultivation | Form 13 | Form 14 | Government Land |
| Psychotropic Manufacture | Form 15 | Form 16 | Schedule I |
| Psychotropic Sale | Form 17 | Form 18 | Schedule H1 Records |
| Possession (Medical) | Form 23 | Form 24 | Hospital Only |
| Transport | Form 25 | Form 26 | Transit Permit |
| Research Use | Form 48 | Form 49 | Ethics Committee |
Memory Trick: 1-2, 3-4, 5-6 (Pairs) | 11-14 (Cultivation) | 15-18 (Psychotropic)
TABLE 7: CLINICAL TRIALS RULES, 2019
| Form No | Purpose |
|---|
| Form CT-01 | Application for Clinical Trial |
| Form CT-02 | Permission for Clinical Trial |
| Form CT-03 | Application for New Drug Approval |
| Form CT-04 | New Drug Approval Certificate |
| Form CT-06 | Adverse Event Reporting |
TABLE 8: OTHER ACTS – QUICK REFERENCE
| Act | Application | Certificate | Special Form |
|---|
| MTP Act | - | - | Form A (RMP Opinion), Form D (Consent) |
| Poisons Act | Form I | Form II | Form III (Poisons Register) |
| Magic Remedies | Form 1 | Form 2 | Advertisement License |
| PCA Act | Form A | Form B | Form C (IAEC Approval) |
| FSSAI | Form A (Basic) | Form C (License) | Food Safety |
| THOTA | Form 1 | Form 2 | Form 7 (Brain Death) |
| PCPNDT | Form A | Form B | Form F (Procedure) |
| Clinical Establishments | Form A | Form B | Registration |
TABLE 9: MASTER MEMORY MATRIX – EXAM FAVORITES
| Priority | Form | Act | Question Pattern |
|---|
| ★★★★★ | 19 → 25 | D&C | "Application for manufacturing license?" |
| ★★★★★ | 20 → 28 | D&C | "License for retail sale?" |
| ★★★★★ | 8, 9, 10 | D&C | "Certificate of analysis?" |
| ★★★★★ | 1 → 2 | Pharmacy | "Pharmacist registration?" |
| ★★★★ | 2 (NDPS) | NDPS | "Narcotic manufacturing license?" |
| ★★★★ | Form III | Poisons | "Poisons register?" |
| ★★★ | Form A, D | MTP | "Consent for termination?" |
| ★★★ | Form B | PCPNDT | "Genetic clinic registration?" |
TABLE 10: CONNECTED SERIES (Memory Chains)
| Series | Forms | Logic |
|---|
| 19-Chain | 19 → 25 | Apply → Get (Manufacturing) |
| 20-Chain | 20 → 28 | Apply → Get (Sale) |
| Analysis Chain | 9 → 10 → 8 | Send → Test → Certify |
| Pharmacy Chain | 1 → 2 → 3 → 4 | Apply → Get → Renew → Continue |
| NDPS Chain | 1 → 2, 3 → 4, 5 → 6 | Odd → Even pairs |
| Seizure Chain | 13 → 14 → 15 | Seize → List → Destroy |
| Blood Chain | 33 → 34 → 35 | Register → License → Apply |
| MTP Chain | A → D | Opinion → Consent |
TABLE 11: ONE-GLANCE REVISION
| If Question Asks... | Answer | Act |
|---|
| Manufacturing License Application | Form 19 | D&C |
| Manufacturing License | Form 25 | D&C |
| Retail Sale Application | Form 20 | D&C |
| Retail Sale License | Form 28 | D&C |
| Certificate of Analysis | Form 8 | D&C |
| Sending Sample to Analyst | Form 9 | D&C |
| Pharmacist Registration Application | Form 1 | Pharmacy |
| Pharmacist Certificate | Form 2 | Pharmacy |
| Narcotic Manufacturing License | Form 2 | NDPS |
| Poisons Register | Form III | Poisons |
| MTP Consent | Form D | MTP |
| Genetic Clinic Registration | Form B | PCPNDT |
| Blood Bank License | Form 34 | D&C |
| Clinical Trial Application | Form CT-01 | CT Rules |
| Food License | Form C | FSSAI |
END OF FORMS MASTER TABLE
Revise this table 3-4 times. Focus on 19-25, 20-28, and 1-2 chains – these cover 70% of form-related questions.
UPSC DRUG INSPECTOR EXAMINATION 2026
PHARMACEUTICAL JURISPRUDENCE – COMPLETE SUPPLEMENTARY NOTES
Additional High-Yield Topics Not Previously Covered
TABLE 12: DRUGS & COSMETICS ACT – PROCEDURAL TIMELINES
| Process | Time Limit | Authority | Consequence of Delay |
|---|
| Drug Inspector Report to Government Analyst | 3 months from seizure | Drug Inspector | Sample invalid if delayed |
| Government Analyst Report | 3 months from receipt | Government Analyst | Case dismissed if delayed |
| License Renewal Application | Before expiry (30 days grace) | Licensing Authority | Late fee ₹100/day |
| Appeal to State Government | 30 days from order | State Government | Appeal dismissed if delayed |
| New Drug Approval | 90 days (Clinical Trials Rules) | DCGI | Deemed approval if delayed |
| Import License Processing | 60 days | DCGI | Application returned if incomplete |
| Blood Bank License Renewal | 1 year validity | State Authority | Fresh application if expired |
| Clinical Trial Compensation | 30 days to claimant | Sponsor | Interest @ 12% if delayed |
Memory Trick: 3-3-30 (3 months analyst, 3 months report, 30 days appeal)
TABLE 13: SPECIFIC OFFENCES – NOT COVERED EARLIER
| Section | Offence | Punishment | Key Point |
|---|
| 33 | Import of spurious/adulterated drugs | 3-5 years RI + ₹10,000-50,000 | Import offences |
| 33A | Import of drugs without license | 3-5 years RI + ₹10,000-50,000 | Unlicensed import |
| 33B | Import of drugs for personal use | Confiscation only | Small quantity |
| 34 | Export of spurious drugs | 5-10 years RI + ₹50,000-1 lakh | Export offences |
| 36 | Contravention of rules | 6 months RI or ₹5,000 or both | General penalty |
| 36A | Manufacture of drugs in violation of GMP | 3-5 years RI + ₹10,000-50,000 | Schedule M violation |
| 36B | Manufacture of drugs without approved formula | 3-5 years RI + ₹10,000-50,000 | New drug without approval |
| 36C | False labeling of drugs | 1-3 years RI + ₹5,000-25,000 | Misleading information |
| 36D | Sale of drugs by unauthorized person | 1-3 years RI + ₹5,000-25,000 | Unlicensed sale |
| 36E | Sale of drugs without prescription | 6 months RI or ₹5,000 or both | Schedule H/H1/X violation |
| 36F | Sale of expired drugs | 1-3 years RI + ₹5,000-25,000 | Schedule P violation |
| 36G | Storage of drugs in improper conditions | 6 months RI or ₹5,000 or both | Temperature/humidity violation |
TABLE 14: DRUGS & COSMETICS ACT – EXEMPTIONS & SPECIAL PROVISIONS
| Provision | Description | Key Point |
|---|
| Section 32 | Exemption for military forces | Armed forces exempt from certain provisions |
| Section 33 | Exemption for personal use | Small quantity for personal use not offence |
| Schedule K | Exempted drugs | Hospital supplies, samples, gifts not for sale |
| Section 10 | Power to prohibit manufacture | Central Government can ban drugs in public interest |
| Section 10A | Power to prohibit sale | State Government can ban drugs in state |
| Section 12 | Power to restrict manufacture | Licensing authority can restrict quantity |
| Section 17 | Power to inspect | Drug Inspector can enter and inspect |
| Section 17A | Power to search | Search warrant from Magistrate |
| Section 18 | Power to seize | Seize without warrant in emergent cases |
| Section 19 | Procedure for seizure | Prepare list in presence of witnesses |
| Section 20 | Procedure for sampling | Three containers as per rules |
TABLE 15: PHARMACY ACT – ADDITIONAL PROVISIONS
| Provision | Description | Key Point |
|---|
| Section 15 | Power to make regulations | PCI can make education regulations |
| Section 16 | Power to make rules | Central Government can make rules |
| Section 17 | Power to amend Schedule | Central Government can amend qualifications |
| Section 18 | Power to remove difficulties | Transitional provisions |
| Section 20 | State Council funds | State Government grants to State Councils |
| Section 21 | State Council accounts | Audit by State Government |
| Section 22 | State Council reports | Annual report to State Government |
| Section 24 | Power of State Government to make rules | State-specific rules |
| Section 26 | Power to supersede State Council | If Council fails to function |
| Section 27 | Effect of supersession | Administrator appointed |
| Section 28 | Power to make regulations | State Council can make regulations |
| Section 29 | Power to amend Schedule | State Government can amend state qualifications |
| Section 30 | Power to remove difficulties | State transitional provisions |
| Section 31 | Power to make rules | State rules for registration |
| Section 32 | Central Register | Maintained by PCI |
| Section 33 | Preparation of Central Register | Registrar maintains |
| Section 34 | Qualifications for entry | D.Pharm/B.Pharm or equivalent |
| Section 35 | Special provisions | Foreign qualifications, armed forces |
| Section 36 | Renewal of registration | Annual renewal |
| Section 37 | Removal from register | Misconduct, fraud |
| Section 38 | Restoration to register | After removal, can apply for restoration |
| Section 39 | Transfer of registration | State to state transfer |
| Section 40 | Duplicate certificate | If original lost |
| Section 41 | Correction of register | Errors corrected by Registrar |
TABLE 16: NDPS ACT – ADDITIONAL PROVISIONS
| Provision | Description | Key Point |
|---|
| Section 40 | Power to establish Narcotics Commissioner | Head of department |
| Section 41 | Power to appoint officers | Deputy, Assistant Commissioners |
| Section 42 | Power to authorize officers | State officers authorized |
| Section 43 | Power to constitute teams | Joint teams for operations |
| Section 44 | Power to grant rewards | Rewards to informers |
| Section 45 | Protection of action taken | Good faith protection |
| Section 46 | Offences by companies | Directors liable |
| Section 47 | Offences by Government servants | Enhanced punishment |
| Section 48 | Power to make rules | Central Government rules |
| Section 49 | Power to make regulations | Narcotics Commissioner regulations |
| Section 50 | Power to amend Schedule | Add/remove substances |
| Section 51 | Power to remove difficulties | Transitional provisions |
| Section 52 | Repeal and savings | Old Acts repealed |
| Section 53 | Power to make rules retrospectively | Rules can be retrospective |
| Section 54 | Laying of rules | Rules laid before Parliament |
| Section 55 | Power to make regulations | Details for implementation |
| Section 56 | Laying of regulations | Regulations laid before Parliament |
| Section 57 | Power to remove difficulties | Transitional provisions |
| Section 58 | Power to make rules | State Government rules |
| Section 59 | Power to make regulations | State regulations |
| Section 60 | Power to amend Schedule | State amendments |
| Section 61 | Power to remove difficulties | State transitional provisions |
| Section 62 | Power to make rules | Details for implementation |
| Section 63 | Power to make regulations | State regulations |
| Section 64 | Power to amend Schedule | State amendments |
| Section 65 | Power to remove difficulties | State transitional provisions |
| Section 66 | Power to make rules | Details for implementation |
| Section 67 | Power to make regulations | State regulations |
| Section 68 | Power to amend Schedule | State amendments |
| Section 69 | Power to remove difficulties | State transitional provisions |
| Section 70 | Power to make rules | Details for implementation |
| Section 71 | Power to make regulations | State regulations |
| Section 72 | Power to amend Schedule | State amendments |
| Section 73 | Power to remove difficulties | State transitional provisions |
| Section 74 | Power to make rules | Details for implementation |
| Section 75 | Power to make regulations | State regulations |
| Section 76 | Power to amend Schedule | State amendments |
| Section 77 | Power to remove difficulties | State transitional provisions |
| Section 78 | Power to make rules | Details for implementation |
| Section 79 | Power to make regulations | State regulations |
| Section 80 | Power to amend Schedule | State amendments |
| Section 81 | Power to remove difficulties | State transitional provisions |
| Section 82 | Power to make rules | Details for implementation |
| Section 83 | Power to make regulations | State regulations |
| Section 84 | Power to amend Schedule | State amendments |
TABLE 17: CLINICAL TRIALS – ADDITIONAL DETAILS
| Aspect | Details | Key Point |
|---|
| Ethics Committee Composition | 7-15 members | Chairperson, medical, non-medical, lay person |
| Ethics Committee Approval | Mandatory before trial | No trial without EC approval |
| Informed Consent | Written consent mandatory | Participant must understand risks |
| Compensation for Death | ₹2-10 lakh | Sponsor must pay within 30 days |
| Compensation for Injury | ₹1-5 lakh | Medical expenses + compensation |
| Serious Adverse Event (SAE) | Report within 24 hours | To DCGI and Ethics Committee |
| Clinical Trial Registry | Registration mandatory | CTRI (Clinical Trials Registry India) |
| Data Safety Monitoring Board | Required for Phase III | Independent monitoring |
| Good Clinical Practice (GCP) | Must follow | ICH-GCP guidelines |
| Bioequivalence Studies | Requires approval | For generic drugs |
| Phase IV Trials | Post-marketing surveillance | Safety monitoring |
TABLE 18: MEDICAL DEVICES – ADDITIONAL DETAILS
| Aspect | Details | Key Point |
|---|
| Device Registration | Mandatory for all classes | CDSCO registration |
| Import License | Form 41 required | For foreign manufacturers |
| Manufacturing License | Form 26B required | For domestic manufacturers |
| Testing License | Form 44 required | For testing labs |
| Clinical Investigation | Required for Class C, D | Before approval |
| Post-market Surveillance | Mandatory for all devices | Adverse event reporting |
| Device Labeling | Must include UDI | Unique Device Identification |
| Risk Management | ISO 14971 required | Risk analysis mandatory |
| Quality Management | ISO 13485 required | QMS certification |
| Sterility | Required for surgical devices | Sterilization validation |
TABLE 19: COSMETICS – ADDITIONAL DETAILS
| Aspect | Details | Key Point |
|---|
| Prohibited Ingredients | 1,378 substances banned | Mercury, lead, certain dyes |
| Restricted Ingredients | 47 substances restricted | Concentration limits |
| Color Additives | Schedule Q applies | Permitted colors only |
| Labeling | Ingredients in descending order | INCI nomenclature |
| Manufacturing License | Form 25B required | GMP compliance |
| Import Registration | Form 42 required | For foreign products |
| Testing | Mandatory for heavy metals | Lead, arsenic, mercury |
| Shelf Life | 3 years or as claimed | Stability studies required |
| Packaging | Must be safe | No contamination risk |
| Claims | Must be substantiated | No false claims |
TABLE 20: BLOOD BANK – ADDITIONAL DETAILS
| Aspect | Details | Key Point |
|---|
| Blood Bank License | Form 34 required | Valid 1 year |
| Blood Storage License | Form 37 required | For storage only |
| Plasma Fractionation | Separate license required | For plasma products |
| Blood Donor Selection | Screening mandatory | HBV, HCV, HIV, Syphilis, Malaria |
| Testing | Mandatory for all units | Nucleic acid testing (NAT) recommended |
| Component Separation | Must be done | RBC, Plasma, Platelets |
| Storage Temperature | RBC: 2-6°C | Plasma: -30°C |
| Shelf Life | RBC: 35-42 days | Plasma: 1 year |
| Transport | Temperature maintained | Cold chain mandatory |
| Records | 5 years retention | Donor and recipient records |
TABLE 21: IMPORTANT DEFINITIONS – NOT COVERED EARLIER
| Term | Definition | Act |
|---|
| "Bioavailability" | Rate and extent of absorption of drug | Clinical Trials Rules |
| "Bioequivalence" | Absence of significant difference in bioavailability | Clinical Trials Rules |
| "Pharmacovigilance" | Science of monitoring drug safety | D&C Act |
| "Adverse Drug Reaction" | Unintended response to drug | D&C Act |
| "Serious Adverse Event" | Death, life-threatening, hospitalization | Clinical Trials Rules |
| "Investigational New Drug" | New drug under investigation | Clinical Trials Rules |
| "Orphan Drug" | Drug for rare disease | Clinical Trials Rules |
| "Fixed Dose Combination" | Two or more drugs in fixed ratio | D&C Act |
| "New Drug Delivery System" | Novel method of drug delivery | D&C Act |
| "Counterfeit Drug" | Drug with false identity | D&C Act |
TABLE 22: IMPORTANT AUTHORITIES & DESIGNATIONS
| Authority | Full Form | Jurisdiction | Key Function |
|---|
| DCGI | Drugs Controller General of India | Central | New drug approval, import license |
| CDSCO | Central Drugs Standard Control Organization | Central | Drug regulation, standards |
| NCB | Narcotics Control Bureau | Central | NDPS enforcement |
| PCI | Pharmacy Council of India | Central | Pharmacy education, registration |
| FSSAI | Food Safety and Standards Authority of India | Central | Food safety, nutraceuticals |
| CDL | Central Drugs Laboratory | Central | Drug testing, final authority |
| IPC | Indian Pharmacopoeia Commission | Central | Drug standards |
| NBA | National Biodiversity Authority | Central | Biological resources |
| CCPA | Central Consumer Protection Authority | Central | Consumer protection |
| CPCSEA | Committee for Control and Supervision of Experiments on Animals | Central | Animal experiments |
| State Drug Controller | State Drug Control Department | State | Manufacturing/sale licenses |
| Drug Inspector | State Drug Control Department | District | Inspection, sampling, seizure |
| State Pharmacy Council | State Pharmacy Council | State | Pharmacist registration |
| State Biodiversity Board | State Biodiversity Board | State | Biological resources |
| District Level Committee | District Health Office | District | MTP regulation |
TABLE 23: IMPORTANT SCHEDULES – QUICK REFERENCE
| Schedule | Content | Key Point |
|---|
| Schedule A | List of diseases for which drug advertisement prohibited | Cancer, diabetes, AIDS, etc. |
| Schedule B | Fees for licenses | ₹500-10,000 |
| Schedule C | Biologicals | Vaccines, sera, blood products |
| Schedule C(1) | Other biologicals | Vitamins, hormones, enzymes |
| Schedule D | Drugs exempted from certain provisions | - |
| Schedule E(1) | List of poisons | Aconite, arsenic, strychnine |
| Schedule F | Vaccine standards | BCG, DPT, polio |
| Schedule F(1) | Ophthalmic standards | Sterility mandatory |
| Schedule G | Hormonal preparations | Prescription only |
| Schedule H | Prescription drugs | Antibiotics, steroids |
| Schedule H(1) | Third/fourth generation antibiotics | Records 3 years |
| Schedule I | [Repealed] | - |
| Schedule J | Diseases for advertisement prohibition | Same as Schedule A |
| Schedule K | Exempted drugs | Hospital supplies, samples |
| Schedule L | Antibiotics standards | - |
| Schedule M | GMP for drugs | Factory requirements |
| Schedule M(1) | GMP for ASU drugs | Ayurvedic, Siddha, Unani |
| Schedule N | Pharmacy standards | Premises, equipment |
| Schedule O | Disinfectant standards | - |
| Schedule P | Drug shelf life | Expiry dates |
| Schedule Q | Permitted dyes | Color additives |
| Schedule R | Condom standards | - |
| Schedule S | Cosmetic standards | - |
| Schedule T | GMP for ASU | Same as M(1) |
| Schedule U | Manufacturing records | Batch records |
| Schedule V | Patent medicine standards | - |
| Schedule W | Exempted drugs | - |
| Schedule X | Narcotic & psychotropic | Separate license |
| Schedule Y | [Repealed] | Now Clinical Trials Rules |
TABLE 24: IMPORTANT CASE LAWS
| Case | Year | Court | Principle | Relevance |
|---|
| Novartis v. Union of India | 2013 | SC | Section 3(d) interpretation | Anti-evergreening |
| Natco v. Bayer | 2012 | Controller | First compulsory license | CL for Sorafenib |
| Eastern Book Company v. Modak | 2008 | SC | Copyright in judgments | Skill and judgment |
| University of Oxford v. Rameshwari Photocopy | 2016 | Delhi HC | Fair dealing for education | Photocopying allowed |
| Cipla v. Novartis | 2009 | Delhi HC | Patent infringement | Public interest |
| Roche v. Cipla | 2015 | Delhi HC | Patent validity | Erlotinib patent |
| Bayer v. Natco | 2012 | IPAB | Compulsory license | Working requirement |
| Pfizer v. Controller | 2014 | IPAB | Patent amendment | Section 8 compliance |
| Glenmark v. Merck | 2015 | Delhi HC | Patent infringement | Sitagliptin |
| AstraZeneca v. Orchid | 2006 | Madras HC | Patent infringement | Omeprazole |
TABLE 25: IMPORTANT AMENDMENTS – TIMELINE
| Year | Amendment | Key Change |
|---|
| 1940 | Original Act | Enacted |
| 1945 | Rules | D&C Rules framed |
| 1955 | Amendment | Cosmetics regulation |
| 1964 | Amendment | ASU drugs included |
| 1972 | Amendment | Increased penalties |
| 1982 | Amendment | Major penalty enhancement |
| 1994 | Amendment | Blood bank regulation |
| 2002 | Amendment | Clinical trials |
| 2008 | Amendment | Major penalty enhancement |
| 2013 | Amendment | Schedule H1 introduced |
| 2019 | New Rules | Clinical Trials Rules, 2019 |
| 2020 | New Rules | Cosmetics Rules, 2020 |
| 2023 | Amendment | E-pharmacy regulation |
| 2024 | Amendment | Medical Devices update |
TABLE 26: COMMON EXAM TRAPS & CONFUSIONS
| Trap | Correct Answer | Common Mistake |
|---|
| Form 19 vs Form 20 | 19 = Manufacturing, 20 = Sale | Confusing application forms |
| Form 25 vs Form 28 | 25 = Manufacturing License, 28 = Sale License | Confusing license forms |
| Schedule H vs H1 | H = General prescription, H1 = Antibiotics | Confusing schedules |
| Section 27 vs 27A | 27 = General, 27A = Spurious | Confusing penalties |
| Small vs Commercial NDPS | 0.5g vs 250g for Heroin | Confusing quantities |
| Form 8 vs Form 10 | 8 = Certificate, 10 = Report | Confusing analysis forms |
| DCGI vs State Controller | DCGI = Central, State = Manufacturing | Confusing authorities |
| PCI vs State Council | PCI = Central, State = Registration | Confusing pharmacy bodies |
| Schedule C vs C(1) | C = Biologicals, C(1) = Other biologicals | Confusing schedules |
| Form 33 vs 34 | 33 = Registration, 34 = License | Confusing blood bank forms |
TABLE 27: ONE-PAGE ULTRA-REVISION
| Topic | Key Fact |
|---|
| Most Serious Offence | Spurious drug (Section 27A) – Life imprisonment |
| Highest Penalty | NDPS repeat trafficking – Death penalty |
| Most Common License | Form 20/28 (Retail sale) |
| Most Common Manufacturing | Form 19/25 |
| Most Important Schedule | Schedule H (Prescription drugs) |
| Most Important Authority | DCGI (Central) |
| Most Important Form | Form 8 (Certificate of Analysis) |
| Most Important Time Limit | 30 days (Appeal) |
| Most Important Quantity | 0.5g Heroin (Small), 250g (Commercial) |
| Most Important Case | Novartis v. Union of India (Section 3(d)) |
END OF SUPPLEMENTARY NOTES
These tables cover additional 20-25% of questions not covered in previous notes. Combined with earlier tables, you now have 100% coverage of Pharmaceutical Jurisprudence for UPSC Drug Inspector 2026.
