News for 'pharmaceutical regulations'

Oxford/AstraZeneca COVID-19 vaccine approved by UK regulator

Oxford/AstraZeneca COVID-19 vaccine approved by UK regulator

Rediff.com30 Dec 2020

The UK's National Health Service was already lining up thousands of medics and volunteers to be ready to deliver jabs up and down the country.

Meet Nirmalaji's Budget Team

Meet Nirmalaji's Budget Team

Rediff.com30 Jan 2025

This will be the first full-year Budget of the BJP-led National Democratic Alliance government since it came to power for a third consecutive term in July last year.

US regulator urges USV to probe staff for inaccurate data reporting

US regulator urges USV to probe staff for inaccurate data reporting

Rediff.com5 Mar 2014

The US Food and Drug Administration has asked USV to probe employees who might have been responsible for inaccurate data reporting.

Pharma cos okay with QR codes to combat counterfeit drugs

Pharma cos okay with QR codes to combat counterfeit drugs

Rediff.com19 Jul 2024

As the Drugs Controller General of India (DCGI) is set to crack down on companies to ensure compliance with printing QR codes on top-selling brands to curb counterfeiting, top pharma companies say they welcome the regulator's mandate and that they are on track. They also view it as a positive step to ensure patient safety. Sheetal Arora, CEO of Mankind Pharmaceuticals, which has already adopted QR codes in 20 of their products, stated: "We strongly advocate for mandatory implementation of barcodes and QR codes on medicines as this initiative will not only protect patients but also strengthen the integrity of our healthcare system by reducing circulation of counterfeit drugs."

Drug regulator to make routine inspection of Chinese suppliers

Drug regulator to make routine inspection of Chinese suppliers

Rediff.com15 Nov 2013

Move follows a spate of international regulatory enforcements on Indian drug firms.

India To Fast-Track Visas For Chinese Nationals

India To Fast-Track Visas For Chinese Nationals

Rediff.com8 Aug 2024

The new guidelines, effective from August 1, aim to expedite visa approvals for nationals from China and other countries sharing land borders with India.

17 persons killed, 33 hurt in Andhra pharma unit fire

17 persons killed, 33 hurt in Andhra pharma unit fire

Rediff.com22 Aug 2024

Harrowing scenes unfolded at the SEZ where the fire ripped through the pharma company. Injured workers with torn clothes and bleeding injuries were seen being shifted to hospitals in ambulances.

Norms: US drug regulator warns Sun Pharma

Norms: US drug regulator warns Sun Pharma

Rediff.com1 Sep 2010

The United States Food and Drug Administration has issued a warning letter to it for manufacturing practice violations at its Cranbury facility in New Jersey.

USFDA pulls up Sun Pharma for lapses in Halol plant

USFDA pulls up Sun Pharma for lapses in Halol plant

Rediff.com14 Jan 2023

The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.

Govt cuts customs duty on 3 cancer drugs

Govt cuts customs duty on 3 cancer drugs

Rediff.com23 Jul 2024

The government proposes to cut custom duties on Trastuzumab Deruxtecan, Osimertinib and Durvalumab from 10 per cent to nil.

GST Gamed For Rs 81,875 cr, Finds Report

GST Gamed For Rs 81,875 cr, Finds Report

Rediff.com16 Sep 2024

The highest-ever goods and services tax (GST) evasion has been done by the online money gaming industry.

After Maggi, regulator now watches food supplements

After Maggi, regulator now watches food supplements

Rediff.com15 Jun 2015

The category is expected to cross Rs 38,400 crore by 2020.

India's First Dengue Vaccine Likely To Be Ready By 2026

India's First Dengue Vaccine Likely To Be Ready By 2026

Rediff.com30 Jul 2024

Dengue has become a major public health concern in India with 289,235 cases reported last year. This year there were 19,447 cases of dengue which resulted in 19 deaths till April 2024.

AstraZeneca withdraws COVID-19 vaccine globally: Report

AstraZeneca withdraws COVID-19 vaccine globally: Report

Rediff.com8 May 2024

Pharma giant AstraZeneca's Covid-19 vaccine is being withdrawn worldwide after the company acknowledged for the first time in court documents that it can cause a rare and dangerous side effect, according to a report in the British newspaper The Telegraph.

Capital Gains Tax Tinkering May Spook Markets

Capital Gains Tax Tinkering May Spook Markets

Rediff.com10 Jul 2024

'Expectations are high regarding the change in LTCG with respect to equity investments.'

US drug regulator finds Indian companies critically ill

US drug regulator finds Indian companies critically ill

Rediff.com24 Sep 2013

The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.

Now doctors can refuse treating violent patients; can't endorse drug brand

Now doctors can refuse treating violent patients; can't endorse drug brand

Rediff.com11 Aug 2023

The National Medical Commission in the Professional Conduct Regulations also bar doctors from endorsing any drug brand, medicine or equipment, or advertise them.

Govt takes steps to regulate e-pharmacies

Govt takes steps to regulate e-pharmacies

Rediff.com8 Sep 2018

Under the proposed rules, individuals or companies will have to register with the central licensing authority to run an e-pharmacy; state-wide registration is not required.

Sun Pharma's growth pill: Specialising in specialty and scaling in India

Sun Pharma's growth pill: Specialising in specialty and scaling in India

Rediff.com25 Mar 2024

Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.

New drug policy, regulations slowing down pharma growth

New drug policy, regulations slowing down pharma growth

Rediff.com31 Oct 2013

Hit by the new drug pricing policy and regulatory interventions, growth rate of the Rs 72,069-crore Indian pharmaceutical market has slowed down to 9.8 per cent in 2013 as compared to 16.6 per cent in 2012, says a report.

Regulator asks traders to stock 55 ICU drugs

Regulator asks traders to stock 55 ICU drugs

Rediff.com18 Apr 2020

This is apart from the requirement to stock hydroxychloroquine (200 mg) and Azithromycin (500 mg) tablets for patients requiring ICU management, asymptomatic healthcare workers and asymptomatic household contacts of positive cases.

'Power shifts to chemists instead of doctors'

'Power shifts to chemists instead of doctors'

Rediff.com22 Aug 2023

'Whichever company offers better incentives, the chemist would prefer it.'

Sebi's proposed tweaks likely to lead to big churn in F&O stocks

Sebi's proposed tweaks likely to lead to big churn in F&O stocks

Rediff.com11 Jun 2024

The market regulator's newly proposed selection criteria for the over Rs 400-trillion-a-day futures and options (F&O) market could pave the way for the entry of popular stocks such as Life Insurance Corporation (LIC) of India, Jio Financial Services, Zomato, Paytm, DMart, and Adani Energy into the derivatives segment. The Indian derivatives market, which accounts for most of the trading volumes, could see big churn with over two dozen exits from the current list of 182 stocks due to an upward revision in the eligibility thresholds.

US regulator not happy with Sun Pharma's reply on import alert

US regulator not happy with Sun Pharma's reply on import alert

Rediff.com21 May 2014

In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.

'Most countries won't forgive deaths of children'

'Most countries won't forgive deaths of children'

Rediff.com22 Nov 2022

'The deaths of the children in the Gambia would batter India's reputation as the developing world's pharmacy.'

Pharma crusader takes India's drug regulators to court

Pharma crusader takes India's drug regulators to court

Rediff.com7 Mar 2016

Dinesh Thakur is famous for exposing Ranbaxy safety problems

Should drug prices be regulated?

Should drug prices be regulated?

Rediff.com30 Nov 2011

Medicines are not commodities.

AstraZeneca admits in court: Covishield causes TTS

AstraZeneca admits in court: Covishield causes TTS

Rediff.com30 Apr 2024

United Kingdom-headquartered pharmaceutical giant AstraZeneca (AZ) has admitted that in 'very rare cases' its Covid vaccine can cause a blood clot related side effect but the causal link is unknown, according to court papers being quoted in the UK media.

Budget 2023: What the pharma, healthcare industry seek

Budget 2023: What the pharma, healthcare industry seek

Rediff.com19 Jan 2023

The government should take measures to promote innovation and R&D while simplifying regulations for the sector in the upcoming Union Budget, as per pharmaceutical industry bodies. Outlining the wish list for the sector in the upcoming Union Budget, Indian Pharmaceutical Alliance (IPA) secretary general Sudarshan Jain said the domestic pharma industry is currently around $50 billion in size and aspires to grow to around $130 billion by 2030 and $450 billion by 2047. "To achieve this vision, the Union Budget 2023-2024 should help fuel innovation and R&D, which will set the pace for propelling the pharmaceutical industry forward," he told PTI.

US regulator tightens drug approval norms

US regulator tightens drug approval norms

Rediff.com29 Jul 2013

Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics

Uzbek syrup deaths: India begins probe, manufacturing halted

Uzbek syrup deaths: India begins probe, manufacturing halted

Rediff.com29 Dec 2022

Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.

3 Indian pharma cos recall products in US market

3 Indian pharma cos recall products in US market

Rediff.com24 Apr 2022

Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.

Indian drug regulator threatens to ban Ranbaxy

Indian drug regulator threatens to ban Ranbaxy

Rediff.com29 Jan 2014

A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.

What lies ahead for Sun Pharma post Ranbaxy merger approval

What lies ahead for Sun Pharma post Ranbaxy merger approval

Rediff.com31 Mar 2015

Sun Pharmaceutical's acquisition of Ranbaxy has received final approvals.

Pharma firms to be hit as drug regulator caps prices

Pharma firms to be hit as drug regulator caps prices

Rediff.com19 Sep 2014

Currently, the govt directly caps prices of 348 formulations at the average price of all medicines in a particular segment with at least 1% market share

Key mantra for India's pharma sector in 2023

Key mantra for India's pharma sector in 2023

Rediff.com21 Dec 2022

Reinvent and innovate will be the key mantra for the Indian pharma industry in the New Year as the 'pharmacy of the world' looks to move from volume to value leadership, amid emerging challenges of inflation and pricing pressures in the global markets. While R&D investment, market competitiveness, regulatory scrutiny, and domestic price regulations are expected to shape the growth of generics and injectable products, concerns such as price control and customs duties on medical equipment will continue to bother the healthcare industry in 2023. The industry believes that in view of India's G20 Presidency, digital health innovation, achieving universal health coverage, improving healthcare infrastructure and delivery will continue to be the key driving factors in 2023.

Pharma regulator fails again

Pharma regulator fails again

Rediff.com23 Dec 2008

The death of a participant in a clinical trial by a Hyderabad-based contract research firm has refocused attention on the practices followed by an industry which is said to have great promise, because it can earn good dollars by leveraging cheap Indian skills.

Indian drug makers face heat of US regulator's crackdown

Indian drug makers face heat of US regulator's crackdown

Rediff.com23 Jun 2013

Data also show that several other leading domestic pharma companies have recalled their products from the US

WHO wrong in linking Gambia kids deaths to Indian cough syrups: DCGI

WHO wrong in linking Gambia kids deaths to Indian cough syrups: DCGI

Rediff.com16 Dec 2022

In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in government laboratory here were found to be complying with specifications and not to have been contaminated with DEG or EG according to the test reports.

Electoral Bonds: The Quid Pro Quo Factor

Electoral Bonds: The Quid Pro Quo Factor

Rediff.com3 Apr 2024

Which entrepreneur would willingly part with her or his hard-earned money for grasping, self-serving politicians? asks Debashis Basu.