CDSCO and state drug licensing, clinical trials, NPPA price control, clinical establishment registration, medical negligence defence and health data under the DPDP Act.
8 regulators, 12 key statutes and 15 compliance obligations, plus 10 common dispute types and 20 due-diligence checks. 11 entries are marked for verification because the rule is state-specific, recently amended, or commenced in stages — those say what to check rather than stating a date we cannot stand behind.
| Regulator | What it decides |
|---|---|
| Central Drugs Standard Control Organisation (CDSCO) | New drug and clinical trial approvals, import registration, medical device classification, and the Drugs Controller General (India). |
| State Drugs Control Administration | Manufacturing and sale licences (Forms 25, 28, 20, 21 and their B-series), inspections and prosecutions under the Drugs and Cosmetics Act. |
| National Pharmaceutical Pricing Authority (NPPA) | Ceiling prices for scheduled formulations, the 10% annual cap on non-scheduled price increases, and overcharging demands. |
| National Medical Commission (NMC) | Medical education, registration of practitioners and professional conduct, replacing the Medical Council of India. |
| State Health Department / Clinical Establishments Authority | Registration of hospitals, nursing homes and diagnostic centres where the Clinical Establishments Act or a state equivalent applies. |
| State Pollution Control Board (SPCB) | Bio-medical waste authorisation and the annual return; consent to operate for larger facilities. |
| Atomic Energy Regulatory Board (AERB) | Licensing of X-ray, CT, radiotherapy and nuclear medicine installations. |
| Appropriate Authority under the PCPNDT Act | Registration of genetic clinics and ultrasound facilities, Form F records and prosecutions for sex determination. |
| Statute | Year | Why it matters |
|---|---|---|
| Drugs and Cosmetics Act | 1940 | With the Drugs and Cosmetics Rules, 1945, the source of every manufacturing, sale, import and labelling licence; sections 27 and 27A carry imprisonment for adulterated and spurious drugs. |
| New Drugs and Clinical Trials Rules | 2019 | Ethics committee registration, trial approval timelines, serious adverse event reporting and compensation — the framework that replaced Schedule Y. |
| Essential Commodities Act | 1955 | The Drugs (Prices Control) Order, 2013 is made under it, which is why an overcharging demand is recoverable as an arrear of land revenue. |
| National Medical Commission Act | 2019 | Repealed the Indian Medical Council Act, 1956; governs registration, the National Register and professional conduct proceedings against doctors. |
| Clinical Establishments (Registration and Regulation) Act | 2010 | Registration and minimum standards for clinical establishments — but it applies only in states and union territories that have adopted it. — verify: Adoption is state by state. Several large states have their own nursing home or clinical establishment legislation instead. Confirm which regime applies. |
| Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act | 1994 | Registration of every ultrasound machine, Form F for every procedure and monthly reporting; offences are non-bailable and the machine is sealed on the spot. |
| Transplantation of Human Organs and Tissues Act | 1994 | Authorisation committee approval for unrelated donors, brain-stem death certification, and criminal liability for commercial dealing. |
| Mental Healthcare Act | 2017 | Advance directives, nominated representatives, admission procedures and the Mental Health Review Boards — a compliance area most hospitals under-document. |
| Bio-Medical Waste Management Rules | 2016 | Authorisation, colour-coded segregation, barcoding and the annual return; the commonest ground for closure notices against small facilities. |
| Consumer Protection Act | 2019 | Medical negligence claims against hospitals and practitioners are consumer complaints; product liability under Chapter VI reaches manufacturers of drugs and devices. |
| Digital Personal Data Protection Act | 2023 | Health records are personal data with no separate 'sensitive' category in the Act, so consent, purpose limitation and breach notification apply to every patient record. — verify: Commencement is phased through the Rules. Confirm which obligations are in force before advising on a timeline. |
| Drugs and Magic Remedies (Objectionable Advertisements) Act | 1954 | Prohibits advertising of treatments for the listed conditions; still actively used against wellness and AYUSH marketing claims. |
| Obligation | Form | When | If missed | Authority |
|---|---|---|---|---|
| Monthly PCPNDT report of Form F records | Form F | Monthly. Send the complete record of every procedure to the Appropriate Authority by the 5th day of the following month. | Non-maintenance or non-submission is itself an offence; machines are sealed and registration suspended. | PCPNDT Act, 1994; PCPNDT Rules, 1996 Rule 9 |
| Bio-medical waste annual return | Form IV | Annual. To the State Pollution Control Board by 30 June for the preceding calendar year. | Authorisation is not renewed, and non-renewal is a ground for closure directions under section 5 of the Environment (Protection) Act. | Bio-Medical Waste Management Rules, 2016 |
| Bio-medical waste authorisation renewal (verify: Validity period differs by state board and by the category of the establishment.) | — | On renewal. Apply for renewal before expiry of the authorisation granted by the SPCB. | Operating without a valid authorisation attracts closure and prosecution. | Bio-Medical Waste Management Rules, 2016 |
| Periodic Safety Update Report for a new drug | PSUR | Half-yearly. Every six months for the first two years after approval, and annually for the subsequent two years. | Approval conditions are breached, and the safety record is the first thing examined if an adverse event becomes litigation. | New Drugs and Clinical Trials Rules, 2019 |
| Serious adverse event reporting in a clinical trial (verify: The 24-hour first report is settled; confirm the current period for the detailed analysis report and the compensation payment timeline in the Rules as amended.) | — | On the trigger event. Report to the licensing authority, the ethics committee and the sponsor within 24 hours of occurrence, and submit the detailed analysis within the further period prescribed. | Suspension of the trial, and the compensation liability is decided against a sponsor who cannot show timely reporting. | New Drugs and Clinical Trials Rules, 2019 |
| Ethics committee registration and re-registration with CDSCO (verify: Confirm the current validity period and the re-registration lead time on the CDSCO portal.) | — | On renewal. Register before reviewing any clinical trial, and apply for re-registration before the certificate expires. | Trials reviewed by an unregistered committee are invalid, which puts the whole dataset at risk. | New Drugs and Clinical Trials Rules, 2019 |
| Price and production returns to NPPA for scheduled formulations (verify: Which form applies, and its periodicity, depends on whether the formulation is scheduled, newly launched or price-approved. Confirm against the Order and current NPPA circulars before diarising.) | Forms under the DPCO, 2013 (Form II / Form III / Form V) | Quarterly. File the prescribed price and production information for scheduled formulations within the period stated in the Order. | Overcharging demands with interest, recoverable as an arrear of land revenue, plus penalty. | Drugs (Prices Control) Order, 2013 |
| Apply the annual WPI-based ceiling price revision | — | Annual. Ceiling prices of scheduled formulations are revised with effect from 1 April each year on the basis of the wholesale price index. | Selling above the revised ceiling is overcharging from the effective date, not from the date the company notices it. | Drugs (Prices Control) Order, 2013 paragraph 16 |
| Check the 10% cap on non-scheduled price increases | — | Annual. The maximum retail price of a non-scheduled formulation may not be increased by more than 10% of the price in the preceding twelve months. | The excess is recoverable as overcharging along with interest. | Drugs (Prices Control) Order, 2013 paragraph 20 |
| Manufacturing and sale licence retention or renewal (verify: The renewal mechanism was changed to a retention-fee model; the cycle and the consequence of late payment differ between states. Confirm with the state licensing authority.) | Forms 25/28 (manufacture), 20/21 and 20B/21B (sale) | On renewal. Pay the retention fee or apply for renewal before the licence lapses, in the manner set by the Drugs Rules as amended. | Manufacture or sale without a subsisting licence is an offence under section 18(c) read with section 27. | Drugs and Cosmetics Rules, 1945 |
| Clinical establishment registration renewal (verify: Applies only where the state has adopted the central Act or has its own registration law; validity periods differ.) | — | On renewal. Renew the provisional or permanent registration before expiry with the state authority. | Running an unregistered establishment attracts monetary penalty and, on repetition, closure. | Clinical Establishments Act, 2010 or the applicable state legislation |
| AERB licence for radiation equipment (verify: Licence validity and RSO requirements vary by equipment class; check the eLORA record for each machine.) | — | On renewal. Obtain and renew the licence for each X-ray, CT, mammography or radiotherapy installation, with a qualified Radiological Safety Officer where required. | Sealing of the equipment and prosecution under the Atomic Energy Act, 1962. | Atomic Energy (Radiation Protection) Rules, 2004 |
| Fire safety and building NOC for the hospital (verify: Renewal dates and validity are state-specific.) | — | Annual. Renew under the state fire services legislation and maintain the evacuation plan and drills. | Sealing, and — the reason this belongs in a legal calendar — the collapse of any defence after a fire. | State fire services legislation |
| Internal Committee annual report under the POSH Act | — | Annual. The Internal Committee prepares an annual report for the calendar year and files it with the District Officer. | Fine and, on repetition, cancellation of the licence or registration to carry on business. | Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 section 21 |
| Product recall and reporting of a quality defect (verify: Recall classification and timelines follow CDSCO guidance rather than a rule with a fixed number of days.) | — | On the trigger event. On a not-of-standard-quality finding or a safety signal, execute the recall and inform the licensing authority. | Prosecution under section 27, cancellation of the licence, and product liability exposure under Chapter VI of the Consumer Protection Act. | Drugs and Cosmetics Act, 1940; CDSCO recall guidelines |
| Dispute | Forum | Note |
|---|---|---|
| Medical negligence claims | District, State and National Consumer Disputes Redressal Commissions | Two-year limitation from the cause of action; expert evidence and the standard of a reasonably competent practitioner decide most cases. |
| Criminal negligence prosecutions of doctors | Magistrate's court, with the Jacob Mathew safeguards | A private complaint should not proceed without an independent medical opinion. |
| Drug prosecutions for not-of-standard-quality or spurious drugs | Special court under the Drugs and Cosmetics Act | Section 25 government analyst reports and the right to have the sample re-tested by the Central Drugs Laboratory. |
| NPPA overcharging demands | Writ petition in the High Court, after representations to NPPA | Demands are recoverable as arrears of land revenue, so interim protection matters more than the merits at the outset. |
| PCPNDT prosecutions | Magistrate's court; suspension by the Appropriate Authority | Offences are cognizable and non-bailable; the machine is sealed at the inspection stage. |
| Product liability for drugs and devices | Consumer commissions under Chapter VI of the Consumer Protection Act, 2019 | Reaches the manufacturer, the service provider and the seller. |
| Professional conduct proceedings against practitioners | State Medical Council, appeal to the NMC's Ethics and Medical Registration Board | Can result in removal from the register, which ends the practice. |
| Insurance and TPA claim disputes | Insurance Ombudsman and consumer commissions | Cashless denial and deduction disputes; hospitals are frequently a necessary party. |
| Employment and bond disputes with resident doctors | Civil court and writ jurisdiction for government institutions | Service bonds are enforced only to the extent of reasonable liquidated damages. |
| Environmental and waste directions | National Green Tribunal and the SPCB's closure directions | Closure directions take effect immediately and are challenged on appeal, not by defending the inspection. |
Loading the full application…