Centre rushes to defend Indian pharma firms
11 years, 9 months ago

Centre rushes to defend Indian pharma firms

The Hindu  

The government, on Monday, said the quality of drugs produced by the pharma industry was of proven global standards and the sector was a highly regulated one. “The pharmaceutical sector is a highly regulated one, and the exports are heavily guided by various regulatory regimes of the importing countries.,” the Commerce and Industry Ministry said in a statement. The government’s reaction came as there were reports about an India-based pharma firm pleading guilty to felony charges relating to manufacture and distribution of certain adulterated drugs made at two India units, and the company agreed to pay $500 million — the largest settlement with a generic medicine maker till date. The government also believes that some of the spurious drugs detected in the international markets, allegedly exported from India, are desperate attempts by other countries getting affected by the strength of the Indian pharma industry, the statement said.

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History of this topic

For small drugmakers playing fast and loose with quality, trouble is on way
1 week, 1 day ago

For small drugmakers playing fast and loose with quality, trouble is on way

Live Mint  

New Delhi: India’s standards watchdog for drug manufacturing will start random checks of small drug companies’ plants by the end of this year, according to two officials aware of the matter who spoke on condition of anonymity. The Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India, will do the checks to review the compliance status …

Centre to review safety, efficacy norms for 13 ‘very old’ drugs
1 month ago

Centre to review safety, efficacy norms for 13 ‘very old’ drugs

Live Mint  

New Delhi: The government body charged with setting quality standards for drugs has launched a review of the safety and efficacy norms for 13 commonly used but “very old” drugs and asked pharmaceutical companies to submit their manufacturing licence approval letters. The Indian Pharmacopoeia Commission, part of the Drugs Controller General of India, said the letter should be issued by …

Govt drawing up parameters to gauge states for drug enforcement, improve quality of products
1 month, 2 weeks ago

Govt drawing up parameters to gauge states for drug enforcement, improve quality of products

Live Mint  

New Delhi: The Union government is drawing up an index to gauge states and union territories on their preparedness to enforce Central regulations on drugs, medical devices and cosmetics, according to officials and documents. Therefore, there is work in plan to bring a Drug Regulatory Index for the State/UTs to get uniformity in enforcement practice," one of the officials said. …

National conference on pharmaceutical quality assurance and GMP guidelines held at AMTZ in Visakhapatnam
2 months ago

National conference on pharmaceutical quality assurance and GMP guidelines held at AMTZ in Visakhapatnam

The Hindu  

A national conference on ‘Enhancing Pharmaceutical Quality Assurance through Good Manufacturing Practices’ was organised by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, in association with the PHD Chamber of Commerce and Industry and the Indian Pharmaceutical Association at Andhra Pradesh MedTech Zone, here on Wednesday. The conference was organised with the technical support of the …

Centre asks MSME drugmakers to submit action plans on quality compliance in 3 months or risk closure
2 months, 1 week ago

Centre asks MSME drugmakers to submit action plans on quality compliance in 3 months or risk closure

Live Mint  

New Delhi: The government plans to give micro, small and medium drugmakers three months to submit their action plans to upgrade plants and comply with the World Health Organization’s good manufacturing practices for life-saving medicines by the end of 2025, failing which they will have to shut down. “The government has sought an upgradation action plan from the companies within …

Health Talk | Why India waiving off local clinical trials for globally approved new drugs is good news
7 months, 2 weeks ago

Health Talk | Why India waiving off local clinical trials for globally approved new drugs is good news

Hindustan Times  

On August 7, India’s drugs regulatory agency, Central Drugs Standard Control Organisation, issued an order that allowed waiving off local clinical trials for approval of certain categories of new and novel drugs in the Indian market that have already been approved for use globally by regulators of countries that follow strict quality control. Local clinical trials or bridging studies as …

Drug Makers To Face Stricter Audits, Surprise Inspections As ‘Schedule M’ Quality Rules Come Into Effect
7 months, 3 weeks ago

Drug Makers To Face Stricter Audits, Surprise Inspections As ‘Schedule M’ Quality Rules Come Into Effect

News 18  

With ‘Schedule M’ coming into effect to improve the quality of India-made medicines, the drug regulator has now instructed officers across the country to begin audits of drug-making units to ensure they are meeting the new standards. Alongside this, the drug regulatory agency Central Drugs Standard Control Organisation has made Schedule M compliance mandatory for issuing new manufacturing licenses and …

India To Update Rules To Match Global Standards For Medicines After Flak Over Drugs
7 months, 3 weeks ago

India To Update Rules To Match Global Standards For Medicines After Flak Over Drugs

News 18  

The long-pending move to make impurity standards for Indian medicines stricter is coming soon, News18 learnt. The Indian Pharmacopoeia Commission is updating its rules to match global standards to check harmful elements in medicines – a significant shift from the current lenient checks on medicines, especially those sold locally. HOW INDIA PLANS TO IMPROVE STANDARDS The Indian Pharmacopoeia Commission, as …

Govt extends deadline for pharma co. bosses to submit unethical marketing practices undertaking till 31 July
8 months ago

Govt extends deadline for pharma co. bosses to submit unethical marketing practices undertaking till 31 July

Live Mint  

New Delhi: The central government has extended the deadline for pharma and medical device company bosses to file their legal self-declarations assuring the government that they will not indulge in unethical marketing practices to promote their drugs. These companies can now file the self-declaration undertaking till 31 July 2024, wherein top executives from these firms must assure the government that …

DCGI inspection brings curtains down on 36% of 400 pharma units; plans for new digital projects
9 months ago

DCGI inspection brings curtains down on 36% of 400 pharma units; plans for new digital projects

Live Mint  

Mumbai: The Drug Controller General of India Rajeev Raghuvanshi on Thursday revealed that the Central Drugs Standard Control Organization has conducted risk-based inspections of over 400 pharmaceutical manufacturing units over the past year and a half, resulting in the closure of 36% of these facilities. “We have been successfully doing risk-based inspections and inspected about 400 manufacturing units and I …

How is India streamlining the pharma sector? | Explained
10 months, 2 weeks ago

How is India streamlining the pharma sector? | Explained

The Hindu  

The story so far: India’s drug regulator, the Central Drugs Standard Control Organisation, has withdrawn powers delegated to State licensing authorities to issue NOCs for manufacture of unapproved, banned or new drugs for export purposes. This latest announcement covering drugs for export comes at a time when India has been under scrutiny for allegations of supplying substandard drugs causing health …

Nigeria Tightens Regulations on Indian Pharma Exports, New Standards May Spark Industry Concerns
1 year, 2 months ago

Nigeria Tightens Regulations on Indian Pharma Exports, New Standards May Spark Industry Concerns

News 18  

The Nigerian drug regulator has recently heightened its standards for Indian drug makers exporting to the country, News18 has learnt. According to the National Agency for Food and Drug Administration and Control — the health regulator of Nigeria — the quality of Active Pharmaceutical Ingredients used in finished pharmaceutical products manufacturing directly impacts the “safety, efficacy, quality, regulatory compliance, consistency, …

Drug regulator flags quality issues, sends notices to 12 firms in Himachal
1 year, 3 months ago

Drug regulator flags quality issues, sends notices to 12 firms in Himachal

Hindustan Times  

The Central Drugs Standard Control Organisation has exposed a grave lapse in pharmaceutical quality control. As many as 14 medicines and injections, manufactured by 12 pharmaceutical industries in Himachal Pradesh, have failed to meet established quality standards. HT Image The samples of medicines manufactured in Himachal whose samples have failed include medicines and injections for the treatment of cancer, heart …

Pharma Star: India Steering Global Supply Chain Away from China - News18
1 year, 3 months ago

Pharma Star: India Steering Global Supply Chain Away from China - News18

News 18  

India’s pharmaceutical industry is at a pivotal juncture. With its well-established prowess in generic drug manufacturing, it has been called on by the world to build a reliable base for the manufacture of raw materials, which offers an opportunity for India to attract the bulk of the pharmaceutical supply chains away from China. “India has started producing 45 APIs after …

Drug regulator flags quality issues, shoots off notices to 19 firms in HP
1 year, 4 months ago

Drug regulator flags quality issues, shoots off notices to 19 firms in HP

Hindustan Times  

: The Central Drugs Standard Control Organisation has unearthed quality lapse in pharmaceutical products, with 24 medicines from 19 Himachal-based industries failing to meet standards and issued show cause notices to these firms. Drug regulator flags quality issues, shoots off notices to 19 firms in HP The tainted drugs are used for critical health conditions, including fungal infections, cancer, type …

From Flawed Data Entries to No Pest Control & More: Inside Details of Probe Into Kala Amb-Based Pharma Firm
1 year, 5 months ago

From Flawed Data Entries to No Pest Control & More: Inside Details of Probe Into Kala Amb-Based Pharma Firm

News 18  

Unusual microbe growth, data integrity issues, missing pest control agreements, mixed-up manufacturing areas and more — the inspection at Himachal Pradesh-based Pushkar Pharmaceuticals in India’s ongoing inspection drive at pharmaceutical firms has revealed more than 30 major and three critical lapses. In snapshot, according to the investigation report accessed by News18, the critical and major observations include “having common manufacturing …

Explained | Why are Indian drugmakers under the lens?
1 year, 8 months ago

Explained | Why are Indian drugmakers under the lens?

The Hindu  

The story so far: Since October last year, Indian pharma companies have been under constant international scrutiny for exporting allegedly contaminated drugs, which have led to deaths of children. Recently, Nigeria raised the red flag on two oral drugs; Cameroon too sounded an alarm over another cough syrup reportedly made in India when several children died. For instance, Ms. Jhaveri …

India ought to work far harder at being the world’s pharmacy
1 year, 9 months ago

India ought to work far harder at being the world’s pharmacy

Live Mint  

Indians have long been proud of their pharmaceutical sector. More than a decade ago, Ranbaxy Laboratories Ltd— then considered the jewel of India’s pharma sector —had to recall tens of thousands of bottles of its generic version of Lipitor for fear that they contained tiny fragments of glass. The saga left neither India’s pharma sector nor its regulators looking very …

‘Indian pharma industry likely to grow to $130 billion in size by 2030’
1 year, 9 months ago

‘Indian pharma industry likely to grow to $130 billion in size by 2030’

The Hindu  

The Indian pharmaceutical industry is projected to grow at a CAGR of over 10% to reach a size of $130 billion by 2030, industry officials said. Supported by the government’s policies and initiatives like ‘Pharma Vision 2020’ and ‘Make in India’, India aims to become a global pharmaceutical hub.” Stating that the pharmaceutical industry is moving towards transparency and visibility, …

Pharma sector needs to focus on quality and affordability: Mandaviya
1 year, 10 months ago

Pharma sector needs to focus on quality and affordability: Mandaviya

Live Mint  

New Delhi: Minister for health and chemicals & fertilizers Mansukh Mandaviya on Saturday advocated for a renewed emphasis on quality, affordability, and innovation in the pharmaceutical industry. Mandaviya chaired a roundtable meeting with the leading CEOs of pharmaceutical industry at the 8th International Conference on Pharma and Medical Device Sector. To maintain its status as the world’s pharmacy, India must …

Centre considering testing drugs at govt. laboratories before exporting
1 year, 10 months ago

Centre considering testing drugs at govt. laboratories before exporting

The Hindu  

Amid quality issues being raised globally for the cough syrups exported by Indian firms, the Centre is actively considering a proposal of testing drugs at government laboratories before they are dispatched to other countries. The apex drug regulatory authority, the Central Drugs Standard Control Organisation has proposed testing the drugs at government labs before exporting, official sources said. The analysis …

India's Pharma Sector In 2023 And Beyond: Shaping New Paradigm With Innovation And Easier Regulatory Processes
1 year, 10 months ago

India's Pharma Sector In 2023 And Beyond: Shaping New Paradigm With Innovation And Easier Regulatory Processes

News 18  

Recently, Union Health Minister, Mansukh Mandaviya highlighted that research and innovation are necessary for the sustained growth of the pharmaceuticals sector. In line with this, the government has initiated various steps such as pharma innovation, new programme to promote research and innovation in pharmaceuticals is being taken up through Centres of Excellences While India’s pharma industry has progressed by leaps …

Safety concerns over e-pharma put Centre in a spot
1 year, 10 months ago

Safety concerns over e-pharma put Centre in a spot

The Hindu  

Central Health Ministry sources say that they are in no mood to give the e-pharma platforms a “free run’’, calling the move far too dangerous. Unlimited accessibility to medicines through e-pharmacy, sale of sub-standard, habit-forming medicines, profiling of patients and buyers, and illegal data collection are the main concerns,’’ said the source, adding that this dynamic industry must be handled …

Centre acts against 34 pharma firms over substandard drugs
1 year, 11 months ago

Centre acts against 34 pharma firms over substandard drugs

Hindustan Times  

The Centre has taken action against at least 34 companies so far in the biggest crackdown against pharmaceutical companies manufacturing substandard drugs, according to people familiar with the matter. According to the “action taken list by state licensing authorities”, a copy of which has been seen by HT, among the companies whose manufacturing licence was suspended or which were asked …

Drafting a road map to bolster the pharma sector
2 years ago

Drafting a road map to bolster the pharma sector

Hindustan Times  

India is known as the pharmacy of the world, and there are several good reasons why it is called so. The country exports pharma products to over 200 countries, and its domestic pharmaceutical industry includes a strong network of 3,000 drug companies and 10,500 manufacturing units. The meeting, attended by representatives from the Union ministry and state governments, had five …

FDA director lauds India’s growth in making medicines
2 years, 1 month ago

FDA director lauds India’s growth in making medicines

Deccan Chronicle  

VISAKHAPATNAM: USA’s Food and Drug Administration quality division director Dr Carmelo Rosa on Thursday lauded India for making continuous progress in the field of manufacturing medicines. Inaugurating the two-day workshop on “Current Good Manufacturing Practices” jointly organised by Andhra University and FDA at the Andhra University campus, Rosa advised that changes in law must be adhered to while manufacturing quality …

Can a centralized regulation help drug quality?
2 years, 1 month ago

Can a centralized regulation help drug quality?

Live Mint  

Waking up to recent deaths in Gambia, Uzbekistan and the US, allegedly caused by toxic and contaminated drugs made in India, the Centre is reportedly planning to centralize drug regulation. The Central Drugs Standard Control Organization, which has zonal and sub-zonal offices and labs across the country, is the apex regulatory body. The state regulators look after licensing and auditing …

Patralekha Chatterjee | Drug regulators in India must do better oversight
2 years, 1 month ago

Patralekha Chatterjee | Drug regulators in India must do better oversight

Deccan Chronicle  

Is Big Pharma hatching a plot to smear India’s low-cost generic drug makers? The World Health Organisation said laboratory tests showed that Marion Biotech’s cough syrups contained unacceptable levels of diethylene glycol and/or ethylene glycol as contaminants. Problems afflicting India’s drug regulatory system is an old story, says Amar Jesani, a well-known public health researcher and editor of Indian Journal …

Budget 2023: An Opportunity To Push India's Pharma Industry Development
2 years, 2 months ago

Budget 2023: An Opportunity To Push India's Pharma Industry Development

News 18  

The Union Budget 2023-24 will be presented on February 1 against the backdrop of a global recessionary fear. Several public sector schemes launched in the past few years, including the Pradhan Mantri Ayushman Bharat Health Infrastructure Mission, have focused on building last-mile infrastructure. Outlining the wishlist for the sector in the upcoming Union Budget, Indian Pharmaceutical Alliance Secretary General Sudarshan …

Govt's 'Surgical Strike' on Pharma Firms Finds Trademark Abuse, Quality Issues, Fake Drugs, Other Ills
2 years, 3 months ago

Govt's 'Surgical Strike' on Pharma Firms Finds Trademark Abuse, Quality Issues, Fake Drugs, Other Ills

News 18  

Infringement of trademarks, selling drugs without bills, buying raw materials without invoices, quality compliance issues and manufacturing fake medicines and more – this is what India’s massive drive to unearth the problems in drug making found. However, another government source privy to the development told News18.com that “Solan, an HP-based company was manufacturing life-saving drugs but selling them without invoices …

'Bid to sully India’s tag as pharmacy of the world'
2 years, 3 months ago

'Bid to sully India’s tag as pharmacy of the world'

Live Mint  

There is an attempt to tarnish India’s reputation as the pharmacy of the world, and it is the government’s duty to safeguard India’s image, Union minister of health and family welfare, and chemical and fertilizer Dr Mansukh Mandaviya said, referring to the controversy around the death of 66 children in Gambia, allegedly after consuming Maiden Pharma’s cough syrup. During the …

India@75: Phenomenal journey of the pharma industry
2 years, 4 months ago

India@75: Phenomenal journey of the pharma industry

Hindustan Times  

The Indian pharmaceutical industry has come a long way since the country’s independence. Among private players, Khwaja Abdul Hamied had already set up one of India’s oldest pharma companies, Cipla in 1935; Indravan Modi set up Cadila pharmaceuticals in the early 1950s, Kallam Anji Reddy set up Dr Reddy’s Laboratories in Hyderabad and Bhai Parvinder Singh set up Ranbaxy in …

No time for placebo: The Hindu Editorial on The Gambia deaths and drugs regulation in India
2 years, 5 months ago

No time for placebo: The Hindu Editorial on The Gambia deaths and drugs regulation in India

The Hindu  

India’s apex drug regulator, the Central Drugs Standard Control Organisation, has barred Haryana-based Maiden Pharmaceuticals Limited from manufacturing medicinal drugs. The provisions of India’s Drugs and Cosmetics Act, in theory, come down heavily on manufacturers for making adulterated drugs, and on gross violations of prescribed manufacturing practices with imprisonment up to 10 years and fines up to ₹10 lakh. Given …

Nigeria accuses Indian drug makers, exporters of unethical practices
2 years, 10 months ago

Nigeria accuses Indian drug makers, exporters of unethical practices

The Hindu  

Accusing Indian pharmaceutical manufacturers and exporters of indulging in unethical and unprofessional practices in connivance with Nigerian importers, Nigeria’s drug regulator NAFDAC has warned them of stringent action. In an alert to Pharmaceuticals Export Promotion Council of India, the National Agency for Food and Drug Administration and Control alleged that the manufacturers from India are resorting to unethical and unprofessional …

Atmanirbhar Bharat: Govt approves ₹15,000 cr to pharma sector to boost local drug production
4 years, 4 months ago

Atmanirbhar Bharat: Govt approves ₹15,000 cr to pharma sector to boost local drug production

Live Mint  

The Cabinet on Wednesday announced production linked incentives for 10 sectors including auto, pharmaceuticals and textiles worth ₹2 lakh crore in a bid to boost manufacturing, make India self reliant and generate employment. Briefing reporters after a meeting of the Cabinet, Information and Broadcasting Minister Prakash Javadekar said production-linked incentives will be offered for sectors such as white goods manufacturing, …

The Legal Quandry Over E-Pharmacies In India: Immediate Need For A Regulatory Framework
4 years, 6 months ago

The Legal Quandry Over E-Pharmacies In India: Immediate Need For A Regulatory Framework

Live Law  

The advent of E-Commerce has changed lives around the World. Despite the lack of explicit regulations, the licensed E-pharmacies are nonetheless legally operating leveraging the blurry difference between online and offline pharmacies under the Drugs & Cosmetics Act, 1940. The Major E -Pharmacy Companies in India assert that they are functioning as a "market place model" meaning thereby they are …

Govt Has Taken Several Measures to Reduce Dependence on Import of Medical Devices: Gowda
4 years, 7 months ago

Govt Has Taken Several Measures to Reduce Dependence on Import of Medical Devices: Gowda

News 18  

The government has taken several measures to reduce the country's dependence on import of medical devices and for the development of domestic capacity in the sector, Minister of Chemicals and Fertilisers D V Sadananda Gowda said on Thursday. However, India is heavily dependent on imports in case of finished medical devices as well as for critical medical device components, Gowda …

Govt to Boost Drug and Medical Device Production to Lessen Reliance on Imports amid Tiff with China
4 years, 8 months ago

Govt to Boost Drug and Medical Device Production to Lessen Reliance on Imports amid Tiff with China

News 18  

The government on Monday released guidelines of four schemes for the development of bulk drug and medical device parks across the country to promote their domestic manufacturing. "In line with the vision of Prime Minister Narendra Modi, the schemes have been conceptualised for making India Atma Nirbhar in pharma sector," Union Minister of Chemicals and Fertilisers DV Sadananda Gowda said …

Dev 360 | Medicine and frontiers: The challenge that China poses
4 years, 9 months ago

Dev 360 | Medicine and frontiers: The challenge that China poses

Deccan Chronicle  

Can India challenge Chinese dominance in pharmaceutical ingredients? Chinese pharmaceutical companies supported by their government set up large fermentation units to mass-produce bulk drugs and intermediates and, at the same time also established intermediates and bulk drug facilities for manufacturing by chemical synthesis route,” says a 2014 white paper by the Indian Drug Manufacturers’ Association. “Indian pharma companies who were …

Pharma sector facing lockdown blues
4 years, 11 months ago

Pharma sector facing lockdown blues

Deccan Chronicle  

Hyderabad: The effect on pharmaceutical companies of the national lockdown has heavily impacted the supply of active pharmaceutical ingredients, especially from China, while the export of drugs to Europe and the United States of America has been curtailed. Dr Arun Singh, an economist, explains, “raw material dependency on China is creating uncertainty regarding normalisation of supply chains. Since 85 per …

Indian drugmakers continue to be in trouble with new FDA warning letters
5 years, 4 months ago

Indian drugmakers continue to be in trouble with new FDA warning letters

Live Mint  

Mumbai: Three major Indian drugmakers received warning letters from the US healthcare watchdog in the last two months, highlighting that the country’s copycat drug sector is still plagued by quality issues amid rising global concerns over tainted drug supplies. Cadila Healthcare Ltd., Glenmark Pharmaceuticals Ltd. and Lupin Ltd. are the latest local medicine makers to be reprimanded by the US …

Where is India’s pharma market headed? Regulatory infrastructure must be put in place to ensure global quality
5 years, 8 months ago

Where is India’s pharma market headed? Regulatory infrastructure must be put in place to ensure global quality

Firstpost  

The pace at which the “pharmacy of the world” is growing, there’s no denying that India is utilising its full potential. The other side—Indian drugs are failing at the World Health Organisation quality standards and those required by the western drug regulating authorities like the Food and Drug Administration. In fact, the ‘Special 301 Report’ by the United States Trade …

Focus to prove quality, now stricter check for generic medicines
6 years, 3 months ago

Focus to prove quality, now stricter check for generic medicines

Hindustan Times  

To boost public confidence in generic medicines, India’s drug controller is putting stringent quality control measures in place. “It is part of the data collected under the BA/BE study, wherein the reference product or the first brand will be given by the drug controller that is duly tested,” said Dr R Chandrashekhar, deputy drug controller, Central Drugs Standard Control Organization. …

Bangladesh’s bulk drugs policy may hurt Indian exports
6 years, 9 months ago

Bangladesh’s bulk drugs policy may hurt Indian exports

Live Mint  

New Delhi: India set out to encourage local manufacturing of bulk drugs by declaring 2015 as the Year of APIs, but there has been little progress on the ground. Meanwhile, Bangladesh on 24 May announced a corporate tax holiday for API and laboratory reagent manufacturers till 2032, as well as many incentives to encourage local manufacturing of drug ingredients. These …

Top Indian drugmakers need at least 5 years to meet global standards: IPA
7 years, 10 months ago

Top Indian drugmakers need at least 5 years to meet global standards: IPA

Live Mint  

Mumbai: India’s big drugmakers will need at least five more years to improve their manufacturing standards and data reliability to a level demanded by international regulators, said a senior industry official. “When you go plant by plant and want to assess whether something is working or not, this is a time consuming process,” D. Shah, secretary general of the Indian …

Drug approvals in India near record despite FDA inspection blitz
8 years, 8 months ago

Drug approvals in India near record despite FDA inspection blitz

Live Mint  

Mumbai/New Delhi: The US Food and Drug Administration has become something of a bogeyman for India’s stock market. But even as the FDA has increased scrutiny of India, it’s been approving generic drug applications from the country’s firms at a record pace, with smaller companies like Aurobindo Pharma Ltd and Glenmark Pharmaceuticals Ltd leading the pack. “You are finding new …

India’s drug monitoring programme struggles to grow fast enough
9 years, 1 month ago

India’s drug monitoring programme struggles to grow fast enough

Live Mint  

Mumbai/New Delhi: Within days of being given a diphtheria jab during a school vaccination drive, 5-year-old Meraj Shabbir Khan’s leg became so swollen that he was hospitalised. India’s six-year-old pharmacovigilance programme, which collects and submits suspected adverse drug reactions to a World Health Organisation database, is key to improving drug safety in a country where medicine consumption is high, experts …

Indian labs deleted test results for US drugs, FDA documents show
10 years, 3 months ago

Indian labs deleted test results for US drugs, FDA documents show

Live Mint  

Washington/Mumbai: In a lab in an Indian village during the height of monsoon season in 2011, a technician hit a delete button—a keystroke that would have consequences three years later. Asked whether felony prosecutions were possible for any of the 12 companies with plants in India on the banned list, Goodin said: “Firms unable to demonstrate control over their processes …

Indian labs deleted test results for US drugs, FDA documents show
10 years, 3 months ago

Indian labs deleted test results for US drugs, FDA documents show

Live Mint  

Washington/Mumbai: In a lab in an Indian village during the height of monsoon season in 2011, a technician hit a delete button—a keystroke that would have consequences three years later. Asked whether felony prosecutions were possible for any of the 12 companies with plants in India on the banned list, Goodin said: “Firms unable to demonstrate control over their processes …

Indian labs deleted test results for US drugs, FDA documents show
10 years, 3 months ago

Indian labs deleted test results for US drugs, FDA documents show

Live Mint  

Washington/Mumbai: In a lab in an Indian village during the height of monsoon season in 2011, a technician hit a delete button—a keystroke that would have consequences three years later. Asked whether felony prosecutions were possible for any of the 12 companies with plants in India on the banned list, Goodin said: “Firms unable to demonstrate control over their processes …

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