Centre Proposes Overhaul of Drug & Medical Device Regulation Under New Bill


The government is developing a legislative overhaul to strengthen regulation across drugs, medical devices, and cosmetics. The proposed Drugs, Medical Devices and Cosmetics Act, 2025 is intended to replace the decades‐old 1940 Drugs and Cosmetics Act and introduce more stringent controls over the sector. 

At a high‐level meeting chaired by the Health Minister, the Drugs Controller General of India (DCGI) presented a draft of the new law. The reforms aim to empower the Central Drugs Standard Control Organisation (CDSCO) with statutory authority, tighten market surveillance, and enhance accountability across the regulatory ecosystem. 

Key features of the draft legislation include:

  • Granting CDSCO the power for immediate enforcement actions against substandard, counterfeit, or falsified drugs and devices. 
  • Digitization of licensing processes to streamline approvals and oversight. 
  • Strengthened coordination between central and state regulators. 
  • Upgrading laboratory infrastructure and testing capacity to ensure robust quality control. 
  • Mandatory transparency and traceability throughout the manufacturing-to-market supply chain. 

A key impetus behind the reform is growing concern over product safety. India has faced scrutiny following cases such as child fatalities from contaminated cough syrup in Madhya Pradesh. 

According to CDSCO’s 2023–24 data, about 3.2% of around 5,500 tested drug samples were found substandard or spurious, leading to enforcement actions at over 40 manufacturing units in recent years. 

The government is expected to introduce the bill in the upcoming Winter Session of Parliament. If enacted, the law would align India’s regulatory framework more closely with global standards, boosting confidence in pharmaceutical and device exports. 

Abbott Issues Nationwide Alert Over Fake Amoxyclav Batches Detected in Indian Market


Global healthcare major Abbott Laboratories has issued a nationwide alert to its distributors and stockists in India after fake batches of its popular antibiotic Amoxyclav 625 were found circulating in the market. The move comes amid growing concerns over the prevalence of counterfeit and substandard medicines in the Indian pharmaceutical supply chain.

Fake Batches Identified and Withdrawn

According to a communication accessed by us, Abbott’s pan-India franchise partner, Biomech Healthcare, circulated an urgent notice to all distributors, directing them to immediately stop the sale, purchase, or stocking of three specific batches of Amoxyclav 625 (10 tablets pack) — namely MFK0076, MKFO692, and MKF0722.

These batches, the communication said, have been “confirmed fake or counterfeit”, and distributors have been “strictly instructed not to procure, stock or sell them under any circumstances.”

The notice reads:

“We bring to your attention that Amoxyclav 625 10s batches MFK0076, MKFO692 and MKF0722 currently in circulation are confirmed fake or counterfeit. Please take necessary actions to protect public health and avoid any potential liability.”

Abbott’s official response to media queries on the issue is still awaited. However, the internal advisory highlights that the company is treating the matter with utmost seriousness and has taken the step as a precautionary measure to protect patient safety and product integrity.

What Is Amoxyclav 625?

Amoxyclav 625 is one of Abbott’s highest-selling antibiotic formulations in India, trusted by doctors and patients for decades. It is a combination of Amoxicillin and Clavulanic Acid, used to treat a wide range of bacterial infections — including pneumonia, ear and sinus infections, urinary tract infections, and skin and soft tissue infections.

Given its widespread use and brand reputation, the discovery of counterfeit versions poses a serious risk not just to patients, but also to the credibility of India’s pharmaceutical ecosystem.

Abbott’s Safety Measures and Distributor Instructions

The communication from Abbott and Biomech Healthcare urged all distribution partners to verify their stocks and ensure purchases are made only through authorised stockists.

“To ensure product authenticity and patient safety, please make all purchases exclusively through our authorised stockists,” the alert stated.

Stockists and distributors have also been directed to “immediately notify” Abbott or Biomech Healthcare if they come across any of the suspicious batches, and to cooperate fully in preventing further circulation of counterfeit stock.

The message further added that this advisory serves as a critical alert to safeguard the integrity of Abbott’s products and the well-being of patients, urging all partners for “prompt attention and responsible action.”

Rising Concern Over Counterfeit Drugs in India

This is not an isolated incident. India has been facing repeated cases of counterfeit and substandard drugs being detected in the market — particularly antibiotics, anti-malarials, and paediatric syrups.

In 2023 and early 2024, several global regulatory authorities, including the World Health Organization (WHO), raised alarms over Indian-manufactured cough syrups found to contain toxic contaminants in countries such as Gambia, Uzbekistan, and Cameroon.

According to WHO estimates, about 35% of fake drugs sold worldwide originate from India, reflecting the scale of the problem.

Experts say that while India is globally recognized as the “pharmacy of the world,” producing over 20% of the world’s generic medicines, it also faces challenges of weak enforcement, parallel supply chains, and inadequate verification systems in the domestic market.

The Economic and Ethical Impact

The presence of counterfeit medicines like fake Amoxyclav not only endangers patient lives but also undermines public trust in pharmaceutical brands and healthcare systems.

“Counterfeit antibiotics are especially dangerous because they may contain subtherapeutic doses or wrong ingredients,” said a senior pharmacologist on condition of anonymity. “This can lead to treatment failure and antimicrobial resistance — a silent pandemic already threatening global health.”

Moreover, counterfeit products eat into legitimate market share, causing financial losses for companies and tax revenue leakages for the government. The WHO estimates that counterfeit medicines cost the global economy over $30 billion annually.

Need for Stronger Regulation and Digital Verification

The incident has reignited discussions around the urgent need for robust track-and-trace mechanisms in India’s drug supply chain. The government has been pushing for implementation of barcoding and digital traceability under the Drug Authentication and Verification Application (DAVA) system and new QR code mandates by the Central Drugs Standard Control Organisation (CDSCO).

Once fully operational, such systems could help pharmacists and consumers instantly verify the authenticity of medicines using a mobile app or QR code scan.

However, experts argue that the system’s success will depend on widespread compliance by manufacturers, wholesalers, and retailers, as well as consumer awareness.

A Call for Vigilance

Abbott’s latest action serves as a reminder that even the most reputed multinational companies are not immune to counterfeiting threats in India’s vast and complex pharmaceutical landscape.

Healthcare professionals are being urged to check packaging carefully, verify batch numbers, and report any suspicious product variations — such as differences in colour, texture, or print quality — to the authorities.

Meanwhile, patients should purchase medicines only from licensed pharmacies, avoid online sellers without verified credentials, and check for manufacturing and expiry details on every strip.

Conclusion

The detection of counterfeit Amoxyclav 625 highlights the growing need for joint accountability between pharma companies, regulators, and the healthcare supply chain. Abbott’s swift action and transparent communication reflect an encouraging step toward patient safety.

But experts say the problem runs deeper — requiring systemic reforms, technology-driven traceability, and strict enforcement to ensure that the medicines reaching Indian households are 100% genuine.

Until then, the call for vigilance continues — for companies, chemists, and consumers alike.

MDC Seeks SNCM, CDSCO Clarification on Midazolam Nasal Spray’s Inclusion in NLEM 2022


The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA) on pricing issues, has sought official clarification from the Standing National Committee on Medicines (SNCM) and the Central Drugs Standard Control Organisation (CDSCO) regarding the inclusion of midazolam nasal spray in the National List of Essential Medicines (NLEM), 2022.

This move comes after Noida-based Biodeal Pharmaceuticals Ltd applied for exemption of its formulation — midazolam nasal spray 1.25 mg — from price control under Para 32(iii) of the Drugs Prices Control Order (DPCO), 2013. The company argued that its product represents a new drug delivery system developed through indigenous R&D, making it eligible for a five-year exemption from price regulation.

However, the situation became complex when CDSCO confirmed that it had granted new drug approval to Biodeal for the formulation on May 5, 2025, while also clarifying that no other strength of midazolam nasal spray had been approved so far. The MDC, on the other hand, observed that the formulation was already listed in NLEM 2022, suggesting that it should have been an already approved drug.

To resolve this discrepancy, the Committee has asked both SNCM—which oversees the revision of NLEM—and CDSCO to provide their views on the approval status and the inclusion process of the drug in the 2022 list.

According to records submitted by Biodeal, the Subject Expert Committee under CDSCO had earlier noted that while midazolam tablets and injection forms were previously approved, the intranasal route had not been authorized before Biodeal’s application—indicating that their formulation was indeed novel.

In August 2025, CDSCO reiterated its position that Biodeal’s midazolam nasal spray 1.25% w/v was the only approved formulation to date. A follow-up communication on September 11, 2025, confirmed this once again.

The MDC emphasized that as per NLEM 2022 criteria, any drug included in the list must already be approved and licensed in India. Moreover, NPPA has already fixed a ceiling price for midazolam nasal spray based on market data showing at least three companies manufacturing or marketing the formulation.

In its September 16, 2025, meeting, the Committee concluded that further clarity from both SNCM and CDSCO is essential before proceeding. Once their inputs are received, the matter will be reviewed again by the MDC.

Under Para 32(iii) of DPCO 2013, manufacturers introducing a new drug with a novel delivery system developed through indigenous research can seek exemption from price control for five years from the start of commercial marketing.

Novo Wins EU Regulatory Backing for Weekly Diabetes Drug Kyinsu


Novo Nordisk A/S’s once-weekly diabetes drug was recommended for approval in the European Union, paving the way for patients to be able to access another option to control their condition.

The European Medicines Agency’s drug review panel recommended approval for Kyinsu in patients with type 2 diabetes. The combination injection of insulin and semaglutide — the active ingredient in Novo’s blockbuster drug Ozempic — is also known as IcoSema.

Trials of the drug show it can help patients with type 2 diabetes control their weight and low blood sugar more than daily injections of insulin. It can be helpful for patients who are unable to control their diabetes with daily insulin.

The long-acting insulin portion of the drug had previously been rejected by the US Food and Drug Administration, which asked for more detail on the manufacturing process and the type 1 diabetes indication.

Pharma Exports to grow at a faster, will touch $31 billion


Pharmaceutical exports, a mainstay of India's trade, set to accelerate 11% in FY25 to record $31 B. Inherent strengths apart, driving the growth will be shortage of drugs in US. Catch all the details

India’s pharmaceutical exports are expected to grow over 11% and touch record $31 billion in FY25 on the back of multiple factors, especially a shortage of drugs in the key U.S. market, a top official of the exporters body under the Commerce Ministry said on Thursday.

For the fiscal ended March 2024, pharma exports, a mainstay in the country’s global trade, rose 9.6% to $27.8 billion. The growth came amid numerous global challenges, Pharmaceuticals Export Promotion Council of India Director General Ravi Uday Bhaskar said.

More than 50% of the exports last fiscal were to highly regulated markets such as North America and Europe. “Pharmaceutical exports to the U.S. increased 15% to more than $8 billion, while the exports to the U.K. were 21% higher at $783 million demonstrating the robust growth of the Indian pharmaceutical industry even in challenging situations,” he told Pharma Lytica expo and conference that got underway in Hyderabad.

As long as India continued to manufacture quality drugs at affordable prices the industry will remain unmatched, he said. Geo-political tensions, economic slowdown and logistical challenges apart, Indian pharma industry faced heat last fiscal over quality issues.

Talking to The Hindu, Mr. Bhaskar said the shortage of generic prescription drugs in the U.S. is expected to increase in the backdrop of some units there shutting down.

Likewise, the demand in shipments to Africa is expected to enhance as non governmental organisations that had shifted their focus to Covid had reverted to supply of free drugs.

Pharma exports to grow at a faster clip, touch $31 billion in FY25

Pharma exports to Africa, which had declined 5% in FY23, ended 8% higher last fiscal.

Barring CIS countries, pharma exports to all other markets were higher year on year in

FY24. As a pointer to the road ahead, the exports in April 2024 rose more than 7%

 


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