Mumbai’s Enforcement Clampdown on Counterfeit Pharma: What Multinationals Need to Know

Introduction

India’s pharmaceutical industry has always told two very different stories. On one side, it’s a global success, respected for its ability to manufacture and supply affordable, life-saving medicines to countries around the world. On the other, there’s a much less flattering reality: the persistent and dangerous spread of counterfeit drugs. These aren’t minor fakes. They’re health hazards that not only put patients at risk but also chip away at the trust the entire system depends on.

That quiet threat is no longer going unnoticed. Mumbai, especially, has turned into a flashpoint. In just the past few months, enforcement agencies have ramped up their efforts in ways we haven’t seen in years. Raids have become more frequent. Seizures are making headlines. Behind closed doors, regulators are doing more than making announcements. They are steadily working to take down the networks that have operated in plain sight for far too long. This doesn’t feel like a routine crackdown. There is a shift happening, and for once, it seems like the system is following through with real intent.

For multinational pharmaceutical companies, this isn’t something to watch from the sidelines. It goes beyond updating compliance manuals or checking boxes. It is about protecting your name, securing your supply chain, and making sure patients are not harmed by something that carries your label but has nothing to do with your medicine. In times like these, waiting quietly is not being cautious — it is being exposed.

The Counterfeit Pharma Menace in India

According to a 2017 WHO report, approximately 10.5% of medicines in low- and middle-income countries are substandard or falsified.[i] India, while being a pharmaceutical manufacturing hub, is not immune to this problem. The issue becomes even more pressing given the size of the Indian pharmaceutical market and its integration with global supply chains.

Mumbai, as India’s commercial capital, has emerged as a focal point in the distribution of counterfeit drugs. Bustling wholesale markets, combined with high population density and a vast logistics network, make it both a target and a base for spurious drug operations.

Recent Enforcement Drive in Mumbai

In a major breakthrough against the counterfeit drug trade, authorities in Maharashtra’s Thane district seized fake medicines worth ₹1.85 crore during coordinated raids by the Food and Drugs Administration (FDA) and local police.[ii] The crackdown, which unfolded over the past few months at two separate locations, was officially disclosed by officials on Monday.

The first site was a warehouse tucked away in Bhiwandi. The second, a smaller facility in Mira Road. Both were quietly funneling counterfeit medicines across state lines. These weren’t fringe products either. Investigators found knockoff versions of widely used antibiotics, painkillers, and erectile dysfunction medications. The packaging was professional. In some cases, nearly indistinguishable from genuine stock from brands like Pfizer, Cipla, and GSK.

FDA investigators said the operation was far more organized than expected. The people behind it weren’t just selling knockoffs. Investigators discovered that the people running the operation had gone to great lengths to appear legitimate. They had fake documents in place, and their packaging looked professional enough to pass through the system unnoticed. What raised serious red flags were the lab reports. Some of the pills had incorrect dosages. Others had no medicinal content at all. In either case, the risks were real. Patients could have easily taken these drugs thinking they were safe, with no idea they were putting their health at risk.

The FDA has confirmed that criminal proceedings will follow under several laws. Officials added that this is just one part of a broader effort to clamp down on what has quietly become a widespread problem in parts of the pharmaceutical supply chain.

India’s Legal Framework Against Counterfeit Medicines

Tackling counterfeit drugs in India involves more than one law or one agency. It’s a legal patchwork that combines criminal provisions, intellectual property enforcement, and regulatory oversight — all of which play a role in identifying and stopping the flow of fake pharmaceuticals.

Drugs and Cosmetics Act, 1940

This is the main law governing drug safety in India. Section 17B spells out what qualifies as a “spurious drug” — essentially, anything sold under someone else’s brand name or made to look like an existing product. The penalties are serious. Section 27(b) allows for prison terms that start at seven years and can go up to life, along with a fine of at least ₹3 lakhs. On the ground, Section 22 gives Drug Inspectors the power to carry out raids, check records, and confiscate suspicious stock. It’s the law most often used when fake medicines are found in the market.[iii]

Bharatiya Nyaya Sanhita, 2023

When criminal intent is involved, the Bharatiya Nyaya Sanhita — India’s updated criminal code — steps in. It replaced the Indian Penal Code and includes provisions tailored to modern offences. Section 176 covers the act of mixing or tampering with drugs meant for sale. Section 177 targets those who actually sell such adulterated products.[iv] There’s also Section 316, which deals with cheating — useful when someone pretends to be a legitimate manufacturer. And Section 324 addresses the sale of goods under false trademarks, which applies directly to counterfeit packaging and branding.

Trademarks Act, 1999

Pharmaceutical companies rely heavily on brand identity. The Trademarks Act offers legal protection when that identity is misused. Under Sections 102 and 103, anyone caught forging or using someone else’s trademark without permission can face criminal prosecution. In civil court, Section 135 provides tools like injunctions and damages. Courts may also grant Anton Piller orders, which let companies carry out surprise searches to preserve evidence before a full trial[v].

Customs Act, 1962 and IPR Enforcement Rules, 2007

Counterfeit drugs don’t just get made locally — many are shipped in from abroad. That’s where the Customs Act becomes important. Section 11 gives the government power to block the import of goods that violate intellectual property rights[vi]. The IPR (Imported Goods) Enforcement Rules of 2007 [vii]back this up by allowing rights holders to record their trademarks with Indian Customs. Once recorded, Customs officers can seize infringing shipments before they enter the domestic market[viii].

Judicial Trends

Indian courts have supported proactive enforcement against counterfeit pharma.

In Pfizer Products Inc. v. Rajesh Chopra[ix], the Delhi High Court granted an Anton Piller order, allowing Pfizer to conduct an ex parte search of the defendant’s premises for counterfeit Viagra. This case established a precedent for swift ex parte relief in cases involving counterfeit life-saving medicines.

In Novartis AG v. Anil Kumar[x], the Delhi High Court restrained the defendants from manufacturing fake "Voveran" and awarded damages[xi]. The judgment reaffirmed that even small-scale infringements involving medical products would attract strong equitable remedies.

More recently, the Bombay High Court in State of Maharashtra v. Rajendra Gawli [xii]upheld a conviction for possession and sale of counterfeit drugs, reinforcing the applicability of both the Drugs and Cosmetics Act and the provisions of criminal law under the BNS.

Challenges for Multinational Pharma Companies

Even though India has solid laws to deal with counterfeiting, global pharma companies often find the actual enforcement much harder.

• Court cases take time, and getting an injunction or a conviction isn’t quick, which can delay responses and even harm public trust.

• Agencies like customs, state police, and regulators don’t always work together smoothly. That lack of coordination slows things down.

• Meanwhile, counterfeiters move through informal supply chains that are tough to monitor.

• What’s also missing is wider use of trademark registration with Customs. Many overseas firms skip this step, so fakes pass through ports without getting flagged.

Compliance Roadmap for Multinational Companies

For multinational pharmaceutical companies, tackling counterfeiting in India takes more than just legal paperwork. It requires a proactive and layered approach, both in the courtroom and across everyday operations. One of the first things companies should focus on is trademark protection — not just registering the mark in India, but also getting it recorded with Customs. This allows enforcement officials to flag and stop fake products right at the border, often before they hit the market.

Then there’s the supply chain. A lot can go wrong if it isn’t monitored closely. Using tools like barcodes, serialization, and basic track-and-trace systems makes it easier to catch unusual activity before it spirals. These methods don’t stop counterfeiting altogether, but they can act as early warning signs.

In parallel, companies need to connect with investigators and local law enforcement. This kind of on-the-ground collaboration makes a real difference — helping identify where fakes are coming from and giving companies a chance to respond with action. When legal proceedings are involved, a mix of civil and criminal action tends to work best. Civil suits can help with injunctions and compensation, while criminal complaints under the Bharatiya Nyaya Sanhita are more effective when the goal is deterrence.

And finally, companies should not overlook education. Running outreach programs — whether aimed at chemists, local clinics, or even end consumers — can build awareness about fake drugs and how to recognize them. It’s a long game, but over time, awareness can shrink the demand for counterfeit medicine.

Conclusion

What’s been happening in Mumbai lately isn’t just routine enforcement. It shows a shift in how seriously the authorities are taking the issue of fake medicines. For global pharmaceutical companies working in India, this is a sign that things are changing, and maybe faster than expected. It’s not just about knowing the law or having a compliance officer in place. It’s about taking a broader view — protecting your brand, yes, but also being part of a system that keeps patients safe. That takes more than legal tools. It means showing up, paying attention, and doing the work before a crisis hits.

Author: Krutha Janani M, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at  Khurana & Khurana, Advocates and IP Attorney.

[i] World Health Organization, Substandard and Falsified Medical Products, WHO (Nov. 2017), https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products

[ii] Swagta Nath, “Fake Medicines Worth Rs 1.85 Crore Endangering Patient Health Seized in Maharashtra” The 420 (March 2025) https://the420.in/fake-medicines-worth-rs-1-85-crore-endangering-patient-health-seized-in-maharashtra/

[iii]Drugs And Cosmetics Act, No. 23 of 1940, INDIA CODE (1940), §§ 17(b), 22, 27(b)

[iv] Bharatiya Nyaya Sanhita, No. 45 of 2023, INDIA CODE (2023), §§ 176, 177, 316, 324

[v] The Trademarks Act, No. 47 of 1999, INDIA CODE (1999), §§ 102, 103, 135

[vi] Customs Act, No. 52 of 1962, INDIA CODE (1962), § 11

[vii] https://www.altacit.com/resources/ip-management/india-ipr-customs-border-protection/ 

[viii] Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007, Gazette Notification No. 49/2007

[ix] Pfizer Products Inc. v. Rajesh Chopra, 2006 SCC OnLine Del 678.

[x] Novartis AG v. Anil Kumar, 2004 SCC OnLine Del 998.

[xi] https://timesofindia.indiatimes.com/city/vijayawada/criminal-contempt-proceedings-against-anil-kumar-for-misleading-the-court-submitting-fake-document/articleshow/119437679.cms

[xii] State of Maharashtra v. Rajendra Gawli, Crim. App. No. 788 of 2022 (Bom. HC).