A drug inspector’s visit takes twenty minutes. The prosecution that follows takes years, and it is usually decided by what happened in those twenty minutes — how the sample was drawn, how it was divided and sealed, what was recorded in the seizure memo, and what the person present signed without reading. By the time the complaint reaches court, the facts are fixed. What remains is whether the procedure the statute prescribes was actually followed.

We act for chemists and retail pharmacies, wholesalers and distributors, manufacturers and loan licensees, importers, cosmetic and medical device companies, and for the directors and qualified persons named alongside them. Matters are conducted before the Judicial Magistrates and Special Courts at Panchkula, Yamuna Nagar and across Haryana and Punjab, before the licensing and appellate authorities of the State Drugs Control Administration, and before the Punjab & Haryana High Court at Chandigarh.

What This Law Covers

The Drugs and Cosmetics Act, 1940 and the Rules made under it regulate the import, manufacture, distribution and sale of drugs and cosmetics in India, supplemented now by the Cosmetics Rules, 2020, the Medical Devices Rules, 2017, the New Drugs and Clinical Trials Rules, 2019, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the price control orders administered by the National Pharmaceutical Pricing Authority.

This is regulatory and penal law concerning licensed medicine, and it is a different subject from the Narcotic Drugs and Psychotropic Substances Act, 1985, which deals with contraband. The two overlap in one place that matters commercially: a chemist selling scheduled habit-forming preparations without prescription or record can find himself facing proceedings under both statutes at once. We deal with narcotics offences separately on our criminal litigation pages.

Prosecutions Under the Act

The common allegations are these:

• Not of standard quality — a sample that fails on assay, dissolution, content or labelling parameters at the Government Analyst’s laboratory.
• Misbranded or adulterated drugs — defects in labelling, packing, expiry declaration or composition.
• Spurious drugs — the gravest category, carrying imprisonment that in aggravated cases extends to life, with the offence cognizable and non-bailable and triable by a Special Court.
• Sale or manufacture without a licence, or in breach of licence conditions — including sale from an unlicensed premises, storage outside the licensed address, and sale of Schedule H, H1 and X drugs without a valid prescription or without maintaining the prescribed register.
• Absence of the qualified person — sale in the absence of a registered pharmacist or competent person, a charge that arises constantly in retail inspections.
• Cosmetics and devices — manufacture, import or sale of cosmetics that are misbranded, spurious or not conforming to standards, and unregistered import.

Prosecution under this Act does not begin with an FIR. A court can take cognizance only on a written complaint by an inspector or an authorised officer, which is itself a point that has to be verified in every case — by whom the complaint was filed, under what authorisation, and after what sanction.

Where These Cases Are Won and Lost

The statute confers real safeguards on the person from whom a sample is taken, and they are ignored more often than they are observed:

• The sampling procedure. The sample must be divided into the prescribed number of portions, each properly sealed and marked, one supplied to the person from whom it was taken, and the fair price paid or tendered. Defects here go to the root of the case.
• The right to controvert the analyst’s report. An accused who intends to challenge the Government Analyst’s report must give notice within twenty-eight days of receiving a copy, on which the sample goes to the Central Drugs Laboratory, whose certificate is conclusive. Delay in supplying the report, or a prosecution launched so late that the retained sample has passed its shelf life, defeats that right, and courts have repeatedly held that the right is not a formality.
• The retailer’s protection. A dealer who purchased the drug from a duly licensed source under a written warranty, stored it as directed and sold it in the same condition in which it was acquired has a statutory defence, provided the source is disclosed. This is the single most important reason for a chemist to keep purchase invoices and warranties in order.
• Liability of directors and partners. A company’s officers are not automatically liable. The complaint must set out how the person was in charge of and responsible for the conduct of the business, and a bare recital of designation does not suffice.

Licence Suspension, Cancellation and Appeals

For a running business, the licence matters more than the prosecution. Suspension or cancellation of a drug licence by the licensing authority follows a show cause notice, and the reply to that notice is where the outcome is decided. An appeal lies to the State Government within the prescribed period, and orders passed without hearing, without reasons, or disproportionate to the breach are open to challenge in writ jurisdiction.

We appear in show cause proceedings, appeals against suspension and cancellation, applications for stay so that a business is not shut while an appeal is pending, refusal and delay in grant or renewal of licences, and disputes over change of premises, addition of a competent person, and conditions imposed on a licence.

Search, Seizure and Stop-Sale Orders

Inspectors have wide powers to enter, inspect, search, seize stock and records, and to issue stop-sale orders. Those powers are not unconditional. We advise on responding to a seizure — what to record, what to sign, what to refuse to sign — and act for the release of goods seized without justification, against stop-sale orders that have no basis in a test report, and against the retention of stock long after any purpose is served. Where a raid has been conducted without the requisite authorisation, that is a matter to raise immediately rather than at trial.

Bail, Trial and Quashing

We appear in anticipatory and regular bail applications, including in spurious drug allegations where the offence is non-bailable, in trial before the Magistrate and Special Court, in applications for compounding and summary disposal of the minor offences the Act permits to be dealt with that way, and in petitions before the High Court to quash complaints that are legally unsustainable — a complaint filed by an officer without authority, a case built on a sample drawn contrary to the Rules, an accused impleaded only by designation, or a prosecution launched after inordinate and unexplained delay.

Advisory and Compliance Work

A prosecution avoided costs less than one defended. We advise pharmacies and pharmaceutical businesses on licence conditions and record-keeping, on Schedule H1 and Schedule X compliance, on labelling and packaging requirements, on advertising restrictions under the Drugs and Magic Remedies Act, on price control obligations and notices from the pricing authority, on registration and import requirements for cosmetics and medical devices, and on responding correctly to the first inspection report rather than to the complaint that follows it.

Documents We Usually Require

• The drug licence, with all endorsements, renewals and conditions
• The inspector’s inspection report, seizure memo and Form receipts issued at the time
• The Government Analyst’s report and the covering letter, with the date of receipt
• The complaint, summons and any order already passed
• Purchase invoices, warranties and stock records for the batch in question
• Records of the registered pharmacist or competent person and attendance
• Prescription registers, Schedule H1 register and sale records for the relevant period
• Constitution documents of the firm or company, and the actual division of responsibility within it

The date on which the analyst’s report was received matters more than any other date in the file. Keep the envelope.

Working With Us

Most of the chemists and small manufacturers who come to us have never faced criminal proceedings before and are more worried about the licence and the reputation than about the trial. We take both seriously, deal with the regulatory side and the prosecution together rather than one after the other, and tell clients honestly where a case is defensible on procedure, where compounding is the sensible course, and where compliance needs to be fixed before the next inspection.

Vaqeelsaab acts in drugs and cosmetics matters from our offices at Sector 27, Panchkula and at the District Court, Jagadhri, appearing before the Magistrates and Special Courts of Haryana and Punjab, the drug licensing and appellate authorities, and the Punjab & Haryana High Court at Chandigarh. If an inspection has taken place or a notice has been received, call +91 94160 09800 or write to info@vaqeelsaab.com with the papers served on you and the date they were received.