Centre raises alarm on adverse reaction caused by widely used life-saving beta blocker drugs

Concerned over the widely used life-saving beta blocker drugs causing adverse drug reactions, the government’s Indian Pharmacopoeia Commission (IPC) has issued an alert about the same.

An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs.

This is important as doctors widely prescribe the beta blocker medication to manage abnormal heart rhythms, prevent heart attack and migraine.

During a recently conducted analysis of Adverse Drug Reactions (ADRs), the commission found that the use of drugs such as metoprolol, propranolol, and atenolol can cause “Hypokalaemia”—a life-threatening condition due to potassium deficiency in the body.

Medically, the drugs metoprolol, propranolol and atenolol are used to treat hypertension in adults, functional heart disorders, migraine prophylaxis, cardiac arrhythmias, management of angina; essential and renal hypertension and other heart disorders.

“The analysis of adverse drug reactions from Pharmacovigilance Programme of India (PvPI) database revealed that beta blocker drugs (Metoprolol, Propranolol, and Atenolol) to cause adverse drug reaction,” stated IPC’s drug safety alert reviewed by Mint.

India’s beta-blocker market is currently valued at $11.06 billion and is expected to touch $15.08 billion by 2030.

India is one of the largest producers of quality medicines and has a robust pharmacovigilance system to monitor the safety profile of marketed pharmaceutical products.

“Healthcare professionals, patients or consumers are advised to closely monitor the possibility of the above ADR associated with the use of above suspected drug. If such a reaction is encountered, please report to the IPC,” it said.

IPC monitors adverse drug reactions among Indian population and helps the Central Drugs Standard Control Organization (CDSCO) take regulatory decisions for the safe use of medicines.

From March till December, around 13 different drugs were found to be showing adverse drug reaction as declared by IPC.

Source : Live Mint

Cipla rolls out mobile application for asthma screening

Drug firm Cipla on Monday said it has launched a mobile application designed to enable the first line of screening for asthma in India. According to the Global Burden of Disease report, the total burden of asthma in India is estimated to be around 34.3 million.

India has a three-fold higher mortality rate and two-fold higher asthma-associated disability burden compared to the global proportion.

This can be attributed, in part, to the underdiagnosis and undertreatment of asthma.

“By leveraging the power of next-gen technologies, we are developing solutions that are fundamentally transforming patient care and enabling better diagnostic, treatment, and management outcomes,” Cipla Managing Director & Global CEO Umang Vohra said in a statement.

The mobile application — CipAir will be available on Android and will be subsequently rolled out on iOS devices, the company stated.

Source : Economic Times

CDSCO Releases Draft Standard Evaluation Protocols For Issuing License For IVDs

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

The drug regulator has said that licensure of IVDs under the MDR requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance and these protocols would be used by IVD manufacturers testing labs in India.

The aim is to facilitate the availability of quality-assured diagnostic kits appropriate for use in India. The guidelines shall establish uniformity in performance evaluation of IVD kits. The performance evaluation is to independently verify the manufacturer’s claim regarding IVD performance.

It has come out with a draft performance evaluation and field evaluation protocols for 14 tests, seeking response from the stakeholders within February 15, 2025.

The tests for which the draft protocol has been formulated include performance evaluation protocol for Chikungunya IgM ELISA, Chikungunya IgM RDT, Chikungunya real-time PCR, Dengue NS1 RDT, Dengue NS1 ELISA, Dengue IgM RDT, Dengue IgM ELISA, Dengue NS1/ IgM combo RDT, Dengue real-time PCR, and Zika virus real-time PCR, and field evaluation protocol for Dengue NS1 RDT, Dengue NS1 ELISA, r Dengue NS1/ IgM combo RDT, and Dengue real-time PCR.

“The protocols are now being placed in the public domain for comments from relevant stakeholders. This window of opportunity will close on 15th February 2025, and, once finalized, there will be minimal scope for change in these documents. Therefore, all interested stakeholders are requested to provide their comments before 15th February 2025…,” said the drug regulator while releasing the draft protocols.

Once the public consultation period concludes, all comments will be reviewed and considered in finalizing the draft protocols before final clearance by ICMR and CDSCO.

After following due procedure as defined in the guidelines for various tests, once any kit is found to be Not of Standard Quality (NSQ), no request for repeat testing of the same kit will be acceptable thereafter, said the drug regulator. Any request for re-validation from the same manufacturer for the same test type will only be entertained if valid proof of change in the kit composition is submitted.

It may be noted that the Central government and the Central drug regulator has been putting various rules and guidelines in position to ensure the safety and quality of medical devices in the market, following the implementation of the MDR, 2017, after the medical devices has been brought under the purview of drug regulators.

Source : Pharmabiz

Dabur India expects low single-digit revenue growth in Q3

Dabur India on Friday said it expects to garner “low single-digit growth” in terms of consolidated revenue during the December quarter and a “flattish” operating profit growth. The company also said it continued to see the impact of inflationary pressures in some segments during the December quarter. At the same time it expects FMCG demand to revive in the coming months.

The FMCG major said that rural consumption for FMCG was resilient during the quarter under review and continued to grow at a faster clip than urban consumption. It noted that modern trade, e-commerce and quick commerce channels continued to post strong growth but the general trade channel was still under pressure.

“Dabur’s consolidated revenue is expected to register low single digit growth during Q3 FY25.We anticipate flattish operating profit growth (in Q3).,” Dabur India stated in its quarterly preview for December quarter in a regulatory filing.

In the Indian market, the company expects the home and personal care segment to post growth of “mid-to-high-single digits”. However, due to the delayed onset of winter, it expects health care segment growth to be “flattish”.

Even the beverages portfolio is expected to report muted performance, it added.

However, the company’s food business is expected to post strong double-digit growth on the back of strong performance of its brands ‘Hommade’ and ‘Badshah’ during Q3.

“ The International Business is expected to register double-digit growth in constant currency terms, led by good momentum in the MENA region, Egypt, Bangladesh and US business.”

Dabur India said it had to take tactical price hikes to partially mitigate inflationary pressures that it witnessed in some segments during the December quarter. The company also leveraged on cost-efficiency initiatives to manage costs during this period.

“With improving macroeconomic indicators, we expect FMCG growth to revive and sequential improvement in demand going forward. We remain committed to delivering superior performance across all business segments and enhancing market share within our portfolio,” the company noted in its regulatory filing. It added that its strategic priorities continue to be focused on brand building, sustained profitable growth, and long-term value creation.

Source : Business Standard

NPPA sets retail prices for 65 drugs, revises ceiling for 20 formulations

The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices for 65 new drug formulations and notified ceiling price fixation of 13 formulations. The regulatory body, under the Department of Pharmaceuticals, also revised the ceiling prices of seven other drugs to include the impact of the 0.00551 per cent increase in drug prices in the National List of Essential Drugs (NLEM), based on the changes in the wholesale price index (WPI) for 2024.
The decision to revise the prices of the formulations was taken during the authority’s 128th meeting on December 12. Prices have been fixed for drugs used to treat Type 2 diabetes, high cholesterol, bacterial infections, and painkillers, whereas drugs with revised ceiling prices include vaccines for rabies, tetanus, and measles, among others, according to multiple notifications from the NPPA.
The revision and fixation of retail and ceiling prices is a routine exercise undertaken by the NPPA. The drug pricing regulator is vested with the responsibility of fixing and revising the prices of pharmaceutical products, enforcing provisions of the Drug Price Control Order (DPCO), and monitoring the prices of both controlled and decontrolled drugs.
In a recent government notification, retail prices of essential fixed combination drugs (FDCs) such as a combination of atorvastatin and ezetimibe tablets, used to treat high cholesterol, by reducing “bad” cholesterol (LDL) and triglyceride levels have been fixed. FDCs are drugs that contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form, usually manufactured and distributed in a fixed ratio.
Other FDCs included in the list include the combinations of dispersible amoxycillin and potassium clavulanate used to treat bacterial infections such as sinusitis, and gliclazide and metformin hydrochloride, which is used to treat Type 2 diabetes. The list also includes dietary supplements such as oral cholecalciferol (Vitamin D3) tablets and antifungal itraconazole capsules.
The 20 drugs whose ceiling prices have been revised include 13 new drugs such as injectable immunoglobins for rabies, tetanus, measles, and BCG, whereas prices of the other seven drugs have been revised after review order to include WPI rate impact.
This list of seven essential formulations includes injectable version of thiamine (Vitamin B1), versions of lignocaine (local anesthetic), tablets for ascorbic acid (Vitamin C), and tablet and liquid versions of clarithromycin (antibiotic).
The government notification mentioned that manufacturers of scheduled formulations selling its branded, generic, or both versions at a price higher than the ceiling price (plus Goods and Services Tax as applicable), shall revise the prices of all such formulations downward not exceeding the ceiling price specified.

Healthcare, pharma sectors raise Rs 14,811 crore via IPOs in 2024

India’s healthcare and pharmaceutical sectors raised Rs 14,811 crore through initial public offerings (IPOs) in 2024, the largest since 2019, driven by strong domestic demand amid expanding global opportunities.
According to data, key contributors to the record fundraising included Sai Life Sciences (Rs 3,043 crore), IKS Health (Rs 2,498 crore), and Sagility India (Rs 2,107 crore). Despite fewer IPOs this year (13 compared with 21 last year), the average issue size saw a considerable jump.
The pharma industry in India is among the top sectors attracting investments. According to the draft red herring prospectus (DRHP) of Sai Life Sciences, “Resilient and sustainable long-term growth has been evident in the global pharmaceutical industry, particularly driven by an increase in chronic diseases, sedentary lifestyles, growth of the geriatric population, and increasing health consciousness.”
The global pharmaceutical market, valued at $1,451 billion in 2023, is projected to grow at a compound annual growth rate (CAGR) of 6.2 per cent and reach $1,956 billion by 2028.
In India, the pharmaceutical sector is among the top ten attractive industries for foreign investment, with exports reaching over 200 countries, including regulated markets like the US and Europe. “India accounts for 20 per cent of global generic drug exports by volume, positioning it as the largest global provider. Pharmaceutical exports totaled $ 25.3 billion in FY23, with March 2023 alone contributing $2.48 billion,” according to the DRHP of Zenith Drugs.
Experts feel that global drug shortages allow Indian drug makers to tap the export market.
“Branded generics drive the domestic market, while export opportunities, especially in the US, have rebounded due to elevated product shortages and facility shutdowns and compliance issues. Emerging categories like biosimilars, GLP-1 drugs, patent expiries and injectables are poised to provide significant future growth, opportunities over mid to long term” said industry expert Shrikant Akolkar, Vice President – research, Nuvama Institutional Equities.
The hospital sector has seen a post-pandemic resurgence, as evidenced by high subscription rates for new IPOs. Companies like Sagility India and IKS Health, which are focused on healthcare service delivery, reflect investor optimism in non-traditional segments of the healthcare ecosystem.
Upcoming opportunities in the sector include off-patent products, biosimilars, and innovative therapies. Analysts also point to the rising demand for healthcare services in Tier-II and Tier-III towns, contributing to long-term growth.

India’s healthcare and pharmaceutical sectors are poised for consistent growth, supported by domestic consumption and export opportunities.

“The strong historical performance, new capex and R&D programs and promising future outlook have instilled confidence in investors, leading to increased interest and investment in the sector,” Akolkar noted.

Source : Business Standard