SPOTLIGHT Pill predicament
With counterfeit drugs inundating Telangana’s pharmaceutical market, authorities are waging a multifaceted battle, because of regulatory gaps and inadequate monitoring systems. Siddharth Kumar Singh highlights the dire consequences on public health and the need for stricter enforcement measures
In many instances, the seized counterfeit drug had no active ingredients whatsoever. This presents grave danger as patients unwittingly administer what they believe to be medication, but receive no therapeutic benefit. V.B. KAMALASAN REDDY, Director General of Telangana DCA
Quacks often resort to prescribing excessive doses of antibiotics and steroids, which can lead a patient to be immunocompromised. DR. RAJEEV NAIK, Member, Telangana State Medical Council
The mehendi was too dark to be real. Manufactured by Shakil Industries in Hyderabad, the ‘Special Karachi Mehndi’ cones were a popular choice among customers for their rich colour and allure. Yet unknown to many, they concealed a dangerous secret — the material in the cones contained picramic acid, a synthetic dye which can cause skin irritation and allergic reactions, ranging from redness and itching to severe symptoms like swelling and blistering.
“We source our mehendi (henna) powder from various States such as Rajasthan, Haryana, and Maharashtra. At times, we obtain it from the Old City area of Hyderabad,” says Adesh, a mehendi artist from Secunderabad. He points out that trust is fundamental in their business since artists cannot always determine if the powder contains harmful chemicals. “But many customers have shared their experiences of skin irritation and allergy after applying mehendi,” he adds.
Earlier this year, officials of the Drugs Control Administration (DCA) raided the cottage industry in Hyderabad’s Mehdipatnam area following information about the unnaturally dark henna. The discovery of the hazardous chemical in mehendi cones is just one of the challenges faced by the DCA, amid a surge in counterfeit drugs and cosmetic products in Telangana.
In another raid conducted in February, DCA officials found eight varieties of ayurvedic medicines being distributed in the market with misleading claims on their labels. These claims purported their effectiveness in treating a range of conditions such as diabetes, kidney stones, impotence, obesity, asthma, menstrual disorders, and optical ailments.
Among the confiscated products was the ‘Diab Amrit capsule’, packaged in boxes containing 30 tablets. Its label proclaims it as an ayurvedic remedy for diabetes. According to the instructions, consuming one capsule twice daily with water, 15 minutes before lunch and dinner, alongside a diet rich in fruits and vegetables while avoiding fried and processed foods, purportedly aids in insulin production and naturally regulates blood sugar levels.
Other seized items included ‘Stone Crush Capsules’ and ‘Stone Crush Syrup’ for kidney stone treatment, ‘Sleemocare kit powder and capsule’ for obesity, ‘Sperm grow kit care and capsule’ for impotency, ‘Migrocare capsules’ for vision irregularities and ocular pressure, ‘Cysto care syrup’ for menstrual irregularities, and ‘Asthma care capsules’ for asthma management.
Addressing subsequent steps following the raid, Drugs Inspector K. Someshwar of Nalgonda region stated that they have issued a notice to the manufacturer, since the label printing is done directly by them. Once the manufacturer’s identity is verified, appropriate legal action would be pursued against them, he had said.
However, even after Telangana DCA seized medicines manufactured by Lifecare Ayurvedic in Rajasthan, these falsified drugs continue to be sold across multiple online platforms.
Drug regulation
Regulating drugs in India involves navigating a complex legal framework primarily governed by the Drugs and Cosmetics Act, 1940, overseen by various ministries, including the Ministry of Health and Family Welfare. This legislation establishes a network of regulatory authorities at both the Central and State levels. Despite drug regulation falling under the jurisdiction of the Central government, ‘public health’ is constitutionally a State subject in India, granting State governments significant control over drug regulation. Statutory bodies known as State Drug Regulatory Authorities (SDRAs) are established under the 1940 Act, to oversee drug regulation within their respective States.
According to a member of the Indian Medical Association (IMA) in Telangana, while the preparation of a new drug necessitates approval from the Central government, vulnerabilities arise at the State level. State drug control bodies frequently struggle with understaffing and inadequate monitoring systems, creating opportunities for companies to introduce spurious drugs into the market sans thorough scrutiny.
Counterfeit medications, also known as spurious drugs, are illicitly manufactured medicines designed to mimic legitimate products, often those belonging to wellestablished brands. The primary objective is to deceive people and capitalise on the popularity of genuine medications. These fraudulent drugs may even display fabricated information about nonexistent manufacturers, creating a false appearance of legitimacy for fictitious companies.
Apart from their failure to effectively treat targeted medical conditions, spurious drugs can lead to severe consequences for patients over time. DirectorGeneral of Telangana DCA V.B. Kamalasan Reddy says that in numerous instances of seized counterfeit medications, they found that those contain no active ingredients whatsoever. “This presents grave danger as patients unwittingly administer what they believe to be medication, and yet receive no therapeutic benefit. Instead, the absence of active ingredients in these deceptive drugs poses serious risks to their health, potentially leading to deterioration,” he adds.
Faking it
Dr. Kiran Madala, Professor and head of Anaesthesia department at the Government Medical College in Nizamabad, Telangana, states that according to the World Health Organization, substandard medicine loses its quality attributes, while falsified medicine intentionally misrepresents its composition, identity, or source. “Both types may contain incorrect ingredients and could have been manufactured in unhygienic conditions, rendering them ineffective for their intended purposes and potentially harmful.
Identifying falsified medical products is exceedingly difficult since they often closely resemble authentic ones,” says Dr. Madala.
He attributes the prevalence of such products in the market to three key factors — constrained access pertaining to issues related to availability, acceptability, and affordability of the product; technical capacity concerning the ability to detect those products; and poor governance, characterised by corruption, unethical practices, and weak administrative structures.
Dr. Madala further explains that prolonged use of counterfeit drugs can have severe repercussions on vital organs such as the kidneys and liver, leading to fatal outcomes. While substandard medicines may not immediately exhibit negative effects, the unpredictable nature of spurious drugs, where consumers are unaware of the actual contents, poses a significant health hazard.
Staying alert and aware
Consumers must remain vigilant against counterfeit drugs, says P. Santosh, a drug inspector. To identify potentially spurious medications, one should compare with previously used products from the same manufacturer, and look for differences in packaging and labelling. Any variations in size, weight, colour, or embossing could signal counterfeit production, as authentic medicines are manufactured with precision.
“Spelling and labelling errors should also raise concerns, along with discrepancies in manufacturing and expiry dates across packaging components. Visual inspection for discoloration, degradation, or unusual odours is crucial, along with ensuring uniformity in blister packs or bottles,” the inspector adds.
A DCA official says most of the seized drugs in Telangana originate from manufacturing facilities located in Uttarakhand, Himachal Pradesh, and specific areas within the National Capital Region (NCR), such as Haryana and Rajasthan. Manufacturing activities are not widespread in Telangana per se. These drugs are then distributed across the country, including Telangana. The official highlights a regulatory loophole, citing lack of oversight by regulatory bodies in those States. “Our jurisdiction is limited to Telangana and not beyond that,” the officer explains.
In recent months, the DCA has also intensified its efforts to check quacks. Dr. Rajeev Naik, a member of Telangana State Medical Council, highlights the repercussions of having unqualified individuals within the medical community. “Such people frequently contribute to misdiagnosis. Quacks often resort to prescribing excessive doses of antibiotics and steroids, which can lead a patient to be immunocompromised,” he says. While there may be no immediate sideeffects of a quack’s diagnosis, the longterm consequences on one’s health could be severe, he warns. For instance, if someone with joint pain receives a prescription for steroids without proper examination, the pain might temporarily subside. However, the longterm effects could manifest after a year, resulting in enduring damage to health.
Dr. Naik also asserts that the proliferation of quacks is partly attributed to the irregular recruitment of doctors by the State health department. “If qualified doctors are regularly recruited, they could be deployed to even the most remote areas, thereby reducing the likelihood of quacks operating in those regions,” he adds.
Discussing future actions, Reddy says that the DCA is cognisant of the widespread marketing of spurious medicines in Telangana and is actively addressing it by deploying specialised teams throughout the State. “Raids will continue, and we will maintain the momentum in combating the issue,” he avers.