Complaining about fake or adulterated medicines
A medicine that does not do what it claims to do — because it is mislabelled, contaminated, sub-potent or entirely counterfeit — is the subject of a dual regulatory regime in India. The Drugs and Cosmetics Act, 1940, administered by the Central Drugs Standard Control Organisation (CDSCO) at the Centre and the State Drug Controllers at the State level, supplies the special law — definitions of "misbranded" (Section 17), "adulterated" (Section 17A), and "spurious" (Section 17B) drugs, the prohibition on their manufacture, sale and distribution (Section 18), and punishment ranging from one year to life imprisonment depending on the gravity of the violation (Section 27). The general penal law in Sections 274, 275 and 276 of the Indian Penal Code, 1860 — re-enacted as Sections 274 to 276 of the Bharatiya Nyaya Sanhita, 2023 — punishes adulteration of drugs, sale of adulterated drugs, and sale of drug as a different drug. The Supreme Court in State of Maharashtra v Sayyed Hassan Sayyed Subhan, (2019) 18 SCC 145 held that the special-law cognizance bar under Section 32 of the 1940 Act does not exclude parallel prosecution under the general IPC provisions. State of Haryana v Brij Lal Mittal, (1998) 5 SCC 343 set the directorial-liability standard. This guide sets out the definitions, the complaint route through the State Drug Inspector, and the cognizance and bail architecture as it now operates.
A counterfeit medicine is two distinct offences sitting in the same fact-pattern — a violation of the special regulatory law that governs drugs as a class of regulated goods, and a violation of the general penal law that punishes acts affecting public health. The special law is the Drugs and Cosmetics Act, 1940, which defines, prohibits and punishes substandard drugs with graduated severity; the general law is Sections 274 to 276 of the Bharatiya Nyaya Sanhita, 2023, which carries forward the IPC provisions on adulteration of drugs, sale of adulterated drugs, and sale of drug as a different drug. The two regimes overlap, and the Supreme Court in State of Maharashtra v Sayyed Hassan Sayyed Subhan, (2019) 18 SCC 145 settled that they are not mutually exclusive — a single fact-pattern can support prosecution under both, with the Section 32 cognizance bar in the special law not operating to shut out the parallel penal-law prosecution. This article sets out the definitions, the complaint route, the cognizance architecture and the standard of directorial liability — in the form a researcher, a patient or a counsellor needs to follow a typical drug-adulteration file.
The three categories — misbranded, adulterated, spurious
The Drugs and Cosmetics Act, 1940 distinguishes three categories of substandard drugs, each with its own definitional section and its own punishment range. The distinction matters — both for the offence charged and for the bail and sentence consequences.
Misbranded drugs — Section 17. A drug is "misbranded" within Section 17 of the Act if it is so coloured, coated, powdered or polished that damage is concealed or it is made to appear of better or greater therapeutic value than it really is; if it is not labelled in the prescribed manner; or if the label or container bears any statement, design or device which is false or misleading in any particular. Misbranding is the lightest of the three categories — it covers cosmetic concealment, label irregularities and misleading claims that fall short of actual substitution or contamination. Punishment under Section 27(d) is up to two years' imprisonment and a fine of not less than rupees twenty thousand.
Adulterated drugs — Section 17A. A drug is "adulterated" within Section 17A if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health; or if its container is composed of any poisonous or deleterious substance; or if it bears or contains a colour other than one prescribed; or if any harmful or toxic substance has been added or has been substituted wholly or in part for the drug. Adulteration is the middle category — it covers contamination, deterioration and harmful additions, and reaches the conduct that makes the drug actively dangerous rather than merely ineffective. Punishment under Section 27(c) is between three and five years' imprisonment and a fine of not less than rupees one lakh or three times the value of the drugs confiscated, whichever is more.
Spurious drugs — Section 17B. A drug is "spurious" within Section 17B if it is manufactured under a name which belongs to another drug; if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive; if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, when the individual or company is fictitious or does not exist; if it has been substituted wholly or in part by another drug; or if it purports to be the product of a manufacturer of whom it is not truly a product. Spurious drugs are the gravest category — the counterfeit medicine, the lookalike, the falsely-attributed product. Punishment under Section 27(a) ranges from imprisonment for ten years which may extend to imprisonment for life and a fine of not less than rupees ten lakh or three times the value of the drugs confiscated, whichever is more; under Section 27(b), where the spurious drug is "likely to cause death or grievous hurt", the minimum is ten years' imprisonment extending to imprisonment for life.
The graduated punishment structure is doctrinally significant — it carries Parliament's recognition that the three categories sit on a spectrum from cosmetic deception (misbranded), through contamination (adulterated), to active counterfeiting that endangers life (spurious). A prosecution under Section 27 turns first on the correct categorisation of the drug under Section 17, 17A or 17B; the laboratory report from the Government Analyst under Section 25 (read with Rule 46 of the Drugs and Cosmetics Rules, 1945) is the operative evidence of the category, and the State Drug Inspector's complaint under Section 32 carries the categorisation into the trial court.
Section 18 — the omnibus prohibition
Section 18 of the Drugs and Cosmetics Act, 1940 is the operative prohibition. It bars any person from manufacturing for sale, selling, stocking or exhibiting for sale, or distributing any drug which is not of standard quality, is misbranded, adulterated or spurious; any drug for the import of which a licence is prescribed, otherwise than under and in accordance with such licence; any drug which by means of any statement, design or device accompanying it or by any other means purports or claims to prevent, cure or mitigate any disease or ailment specified in the Schedule J to the 1945 Rules (a list of incurable diseases for which advertisement is prohibited); and so on. Section 18(c) — the residual provision — prohibits the manufacture or sale of any drug except under, and in accordance with the conditions of, a licence issued for such purpose.
Section 18A imposes a parallel disclosure obligation — any person making, selling or distributing a drug must, on the demand of a Drug Inspector under Section 21, disclose the name of the manufacturer and any other person from whom he acquired the drug. The provision is the practical hinge of investigation; it permits the Drug Inspector to trace the supply chain backwards from the retail pharmacy to the wholesaler and the manufacturer, and to lay the foundation for the directorial-liability prosecution against the manufacturer under Section 27 read with Section 34 (the offence-by-company section). The information is admissible evidence in the prosecution that follows; failure to disclose is itself an offence under Section 27.
The Drug Inspector — investigation, sampling and complaint
The Drug Inspector is the operational backbone of drug-regulation enforcement. The post is constituted under Section 21 of the Act read with Rule 50 of the 1945 Rules; the Inspector is appointed either by the Central Government or, in respect of drugs other than those sold by the manufacturer or the importer for the first time, by the State Government. Section 22 gives the Inspector wide powers — to enter and inspect any premises where any drug is being manufactured, sold or distributed; to take samples of any drug for analysis; to require the production of any record, register or other document relating to the manufacture, sale or distribution of the drug; to investigate any complaint made to him in writing; and to exercise such other powers as may be necessary for carrying out the provisions of the Act.
Section 23 sets out the procedure for sampling — the Inspector must, at the time of taking the sample, inform the person from whom it is taken of his intention to take the sample, divide the sample into four portions, mark and seal each portion, send one sealed portion for analysis to the Government Analyst under Section 25, and retain the remaining three in the manner prescribed in Rule 46. The Government Analyst's report under Section 25 is conclusive evidence of the facts stated in it, unless the accused notifies the prosecution within twenty-eight days that he intends to challenge the report, in which case the second sealed portion is sent to the Central Drugs Laboratory whose report is final and conclusive. The procedure is designed to give the accused a procedural opportunity to test the chemical evidence, while preserving the evidentiary value of the Government Analyst's report as the default.
A patient or consumer who has acquired a substandard or counterfeit medicine has the operational route of a written complaint to the State Drug Inspector — addressed to the office of the State Drug Controller, with the medicine sample (in its original packaging, with batch number, manufacturing date, expiry date, name and address of the pharmacy where it was bought), the purchase receipt, and a brief description of the suspected substandard or counterfeit character. The Inspector, on receipt, is bound under Section 22 to investigate; the typical investigative steps are the seizure of stock from the pharmacy, sample collection and dispatch to the Government Analyst, tracing the supply chain backwards under Section 18A, and filing the complaint under Section 32 once the laboratory report comes in.
Section 32 cognizance — the special-law route
Section 32 of the Drugs and Cosmetics Act, 1940 is the cognizance-control provision. It provides that no court shall take cognizance of any offence under the Act except on a complaint made by an Inspector or by any gazetted officer of the Central or State Government authorised in writing in this behalf by the Central Government or a State Government — or, in the case of a private complaint, only with the prior written consent of the same authority. The provision is the operational reason that drug-adulteration prosecutions cannot ordinarily be initiated by a private person filing an FIR under Section 173 of the Bharatiya Nagarik Suraksha Sanhita, 2023 [Section 154 CrPC]; the State Drug Inspector is the gatekeeper of the prosecution, and the patient's role is to trigger the Inspector's investigation by a written complaint.
The Drugs and Cosmetics Act, 1940 also displaces some of the standard procedural law in the criminal courts. Section 36AB makes offences under Section 27(a) (spurious drugs likely to cause death or grievous hurt) and Section 27(b) (other spurious drugs) cognizable and non-bailable; offences under Section 27(c) (adulterated drugs) and Section 27(d) (misbranded drugs) remain non-cognizable. The Special Court framework under Sections 36A to 36AC — added by the 2008 amendment after the recommendations of the Mashelkar Committee on Spurious Drugs — provides for designation of Special Courts at the Sessions level for trial of offences under the Act; the Special Court has the powers of a Court of Session under the Bharatiya Nagarik Suraksha Sanhita, 2023 [CrPC] and the trial is to be conducted in a day-to-day basis to the extent practicable.
The Supreme Court in Premier Suppliers Pvt Ltd v State of Maharashtra, and a line of subsequent decisions, has clarified that the cognizance bar in Section 32 operates only in respect of offences under the 1940 Act — it does not bar prosecution under other statutes, including the parallel offences under the BNS [IPC]. The bar is jurisdictional for the special-law offence only; the general criminal law is not affected. The clarification matters because it permits the State to maintain a parallel prosecution under both regimes — one driven by the State Drug Inspector under the 1940 Act, the other driven by the regular police machinery under the BNS — without the procedural infirmity of an unauthorised complaint under the 1940 Act.
The parallel penal route — BNS Sections 274 to 276
Sections 274, 275 and 276 of the Bharatiya Nyaya Sanhita, 2023 — re-enacting Sections 274, 275 and 276 of the IPC substantially intact — provide the general penal-law route. Section 274 punishes whoever adulterates any drug or medical preparation in such a manner as to lessen the efficacy or change the operation of such drug or medical preparation, or to make it noxious, intending that it shall be sold or used for, or knowing it to be likely that it will be sold or used for, any medicinal purpose as if it had not undergone such adulteration. The punishment is imprisonment of either description for a term which may extend to one year, or with fine which may extend to five thousand rupees, or with both. Section 275 punishes the sale of a drug knowing it to have been so adulterated. Section 276 punishes the sale, offer for sale, or issue from a dispensary for medicinal purposes of any drug or medical preparation as a different drug or medical preparation — the counterfeiting offence in penal-code form. The BNS retained the IPC's six-month-to-one-year punishment range for Section 274 and Section 275, but the fine has been substantially enhanced and several State amendments — Uttar Pradesh, West Bengal — have made the offence punishable with imprisonment for life within their territory.
The doctrinal architecture of the BNS sections is that adulteration is complete on the introduction of the adulterant in the drug, provided it is meant for the purpose of sale, actual or likely (the rule applied in Joseph Kurian v State of Kerala, AIR 1995 SC 4 in the parallel context of Section 272 IPC — adulteration of food and drink — and carried over to Sections 274-276). The sale offence under Section 275 BNS [275 IPC] requires the knowledge or reason to believe that the drug has been adulterated; the substitution offence under Section 276 BNS [276 IPC] does not require any actual adulteration but is committed by selling one drug as a different drug — the substitution of savin for saffron in Knight v Bowers, (1885), the classic illustration the Ratanlal commentary recites.
The Supreme Court in State of Maharashtra v Sayyed Hassan Sayyed Subhan, (2019) 18 SCC 145 settled the question of whether prosecution under the BNS [IPC] sections is shut out by the cognizance bar under Section 32 of the 1940 Act. The answer is no — there is no implied repeal of the BNS sections by the 1940 Act, the two statutes operate in parallel fields, the Section 32 bar is jurisdictional only for the 1940 Act offence, and a single fact-pattern can support prosecutions under both — the special-law prosecution driven by the Drug Inspector's complaint, the general-law prosecution driven by the regular police FIR. The earlier line of decisions in Mahesh Ramchandra Jadhav v State of Maharashtra, (1999) on the food-adulteration side, and Rajiv Kumar Gupta v State of Maharashtra, (2005), had set out the parallel-prosecution principle for the IPC/Prevention of Food Adulteration Act overlap; Sayyed Hassan confirmed the same principle for the IPC/D&C Act overlap.
Directorial and corporate liability — Brij Lal Mittal
The 1940 Act treats offences committed by companies in the standard penal-code manner — Section 34 provides that where an offence under the Act is committed by a company, every person who, at the time the offence was committed, was in charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly. The proviso lets a person off if he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of the offence. Sub-section (2) extends liability to directors, managers, secretaries and other officers where the offence has been committed with their consent or connivance or is attributable to any neglect on their part.
The Supreme Court in State of Haryana v Brij Lal Mittal, (1998) 5 SCC 343 set the operative test for directorial liability — a director is not, by virtue of his directorship alone, liable for an offence committed by the company under Section 34; the prosecution must specifically plead and prove that the director was in charge of, and responsible to, the company for the conduct of its business at the time the offence was committed. The mere fact that a person is a director of the company is not sufficient. The decision has been cited in dozens of subsequent rulings — across the Negotiable Instruments Act Section 138 line, the Food Safety and Standards Act line, and the labour-law offences line — for the same proposition, and it remains the doctrinal anchor for any quashing petition by a director who has been arraigned in a drug-adulteration prosecution without a specific allegation of his role in the day-to-day business.
Other regulatory routes — DPCO, Pharmacy Act, Consumer Forum
The drug-regulation grid is not exhausted by the 1940 Act and the BNS sections. The Drugs (Prices Control) Order, 2013, issued under Section 3 of the Essential Commodities Act, 1955, regulates the prices of scheduled drugs — the National List of Essential Medicines drugs are subjected to ceiling prices fixed by the National Pharmaceutical Pricing Authority (NPPA) under paragraph 4 of the DPCO, 2013. Overpricing — sale of a scheduled drug above the ceiling price — is a violation of paragraph 19 of the DPCO, 2013 and is punishable under Section 7 of the Essential Commodities Act, 1955 with imprisonment which may extend to seven years and with fine. A patient who has been charged above the ceiling price for a scheduled drug can complain to the NPPA, the State Drug Controller, or both.
The Pharmacy Act, 1948 supplies the regulatory framework for pharmacy practice. Section 42 of the Pharmacy Act, 1948 prohibits any person other than a registered pharmacist from compounding or dispensing any medicine on the prescription of a medical practitioner; violation is punishable with imprisonment up to six months or fine up to one thousand rupees. The provision is the legal basis on which a complaint against an unqualified compounder dispensing prescription medicines is laid — though the Pharmacy Act offence is in practice less frequently prosecuted than the D&C Act offence because the pharmacist-registration enforcement is comparatively lax.
The Consumer Protection Act, 2019 supplies the compensation route. A drug that is adulterated, misbranded or spurious is a "defective good" within Section 2(11), the manufacturer and seller are "manufacturer" and "trader" within Section 2(34) and 2(46), and the patient who has consumed it is a "consumer" within Section 2(7). The complaint lies before the District Commission under Section 35, the State Commission under Section 47 or the National Commission under Section 58 depending on the value of the claim, with summary procedure under Section 38. The Supreme Court in IMA v V P Shantha, (1995) 6 SCC 651 brought medical services within the consumer-forum jurisdiction; the consequence is that the patient can claim compensation against the manufacturer, the pharmacy and the doctor (where the doctor was negligent in prescribing or administering the drug) before the consumer forum, in addition to any criminal prosecution that may run in parallel.
What a complainant has to do — and what the State has to do
The operational sequence for a patient who has acquired a fake or adulterated medicine has three stages. First — preserve the evidence. The medicine sample in its original packaging, with batch number, manufacturing date, expiry date, name and address of the pharmacy where it was bought; the purchase receipt; and a written record of the symptoms, the prescribing doctor's prescription, and the dispensing date and quantity. Second — file a written complaint with the State Drug Inspector at the office of the State Drug Controller. The complaint can be filed in person or by post; the format is informal but should set out the facts, the apparent character of the substandard or counterfeit medicine (misbranded, adulterated or spurious — the patient need not finalise the category, the Inspector and the Government Analyst will), and the supporting documents. Third — parallel route, where the symptoms are serious — a written complaint at the local police station seeking registration of FIR under Section 173 BNSS [Section 154 CrPC] for offences under Sections 274 to 276 of the BNS [IPC]; the police are bound to register the FIR if the complaint discloses cognizable offences, subject to the preliminary-enquiry procedure under Lalita Kumari v Govt of UP, (2014) 2 SCC 1.
The State's reciprocal duties run on the same three tracks. The Drug Inspector under Section 22 must investigate the complaint, take samples under Section 23, secure the Government Analyst's report under Section 25, trace the supply chain backwards under Section 18A, and file the complaint under Section 32 in the Special Court. The police, in respect of the BNS [IPC] offence, must investigate under Section 175 BNSS [Section 156 CrPC], record statements under Section 180 BNSS [Section 161 CrPC], and submit a report under Section 193 BNSS [Section 173 CrPC]. The Special Court, on receipt of the Section 32 complaint, must take cognizance and proceed under the Special-Court procedure in Sections 36A to 36AC. The two prosecutions run in parallel; the conviction in one is not, by itself, conviction in the other, but both prosecutions can be sustained on the same fact-pattern after Sayyed Hassan.
The practical takeaway for a researcher is that the drug-adulteration grid is operationally dense but doctrinally coherent. The 1940 Act supplies the regulatory definitions and the special-law prosecution; the BNS supplies the penal-code parallel; the DPCO supplies the price-control overlay; the Pharmacy Act supplies the dispensing-qualification overlay; the Consumer Protection Act supplies the compensation route. The Drug Inspector is the State's operational hub; the Government Analyst is the evidentiary hub; the Special Court is the trial hub. The patient's complaint sets the machinery in motion; the rest is investigation and evidence.