spiderman
Member
- Joined
- Sep 11, 2014
- Messages
- 177
This article was sent to me via a good friend who lives in India....It tends to affect a lot of people worldwide,,,,,
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Last year Teva recalled 40,000 bottles of medicine manufactured for it by India’s Emcure Pharmaceuticals.
In July, the FDA issued an “import alert” that effectively banned the import of drugs from Emcure’s Hinjwadi plant.
So far this year, six Indian co's have had their manufacturing sites blacklisted by the FDA. As a result, there are now 39 drugmaking facilities in India — owned by 27 different companies that have since lost clearance due to regulatory problems.
Indian companies make around 30 to 40% of the generic medicines taken in the US — a market worth $44bn, according to IBISWorld — as well as many drugs and vaccines used by global aid agencies for health programmes in poorer countries.
Now, they face a serious credibility crisis, as they battle to allay western regulators’ concerns about their manufacturing practices — especially the reliability of data from trials of their medicines.
Last month, the European Union banned 700 Indian-made generic drugs, citing doubts about the credibility of clinical trials carried out by GVK Biosciences, a Hyderabad-based research organisation.
Then, last week, the World Health Organisation warned Svizera Laboratories — one of four suppliers of tuberculosis drugs to its Stop TB Partnership — that inspections in July had raised “serious concerns about the integrity, reliability and accuracy of data generated and available at your manufacturing site, and on your ability to prevent contamination and cross-contamination of your products”.
“Trust has eroded so much among foreign regulators, I don’t think they take anything that’s said at face value,” warns Dinesh Thakur, the whistleblower in the Ranbaxy case, who now runs a consultancy focused on the pharmaceutical supply chain.
Nor is this a problem solely for small, obscure companies in India. Overseas regulators have been scrutinising and banning products from some of India’s biggest and most reputable groups — including Sun Pharmaceuticals, IPCA, and Wockhardt — many of which have ongoing relationships with large multinational drug companies.
Last year, growth in Indian drug exports slowed to 3%, according to the Pharmaceutical Export Council of India, a government organisation. For much of the past decade, growth had stood at a robust 12 to 13% a year.
Influential US pharmacy benefit managers, such as ExpressScripts and MerckMedco, are also increasingly concerned about their dependence on Indian suppliers — fearful that imports to the US market may be abruptly banned.
DG Shah, secretary of the Indian Pharmaceutical Alliance, an association of India’s top drug companies, acknowledges the industry is struggling to meet stringent US standards.
He says this reflects the inadequate training of lab technicians and supervisors, rather than any deliberate attempt to manipulate or falsify data by the companies’ management.
But Mr Thakur, the former whistleblower, says the problem is the lack of value that most Indians place on precision — and a general acceptance of low standards by company workers, owners and managers. “As a culture, we’ve accepted that if it meets 80 per cent of our requirements, that’s OK,” he says. “This is not a systemic pharmaceutical industry problem. This is a systemic cultural problem.”
Murali Neelakantan, former general counsel for Cipla, India’s fourth-largest drugmaker by sales, agrees that the Indian laboratory practices raising concerns among regulators have deep roots, but that it is an “organisational culture issue” for companies to train and incentivise their workers to follow global best practices, including sounding the alarm when tests point to quality problems.
“Indians as a rule don’t like to say no, and don’t like to give bad news and therefore test results always have to come out good,” he suggests. “You know what the test is supposed to say and you try to show that.”
.......................................................................................
Last year Teva recalled 40,000 bottles of medicine manufactured for it by India’s Emcure Pharmaceuticals.
In July, the FDA issued an “import alert” that effectively banned the import of drugs from Emcure’s Hinjwadi plant.
So far this year, six Indian co's have had their manufacturing sites blacklisted by the FDA. As a result, there are now 39 drugmaking facilities in India — owned by 27 different companies that have since lost clearance due to regulatory problems.
Indian companies make around 30 to 40% of the generic medicines taken in the US — a market worth $44bn, according to IBISWorld — as well as many drugs and vaccines used by global aid agencies for health programmes in poorer countries.
Now, they face a serious credibility crisis, as they battle to allay western regulators’ concerns about their manufacturing practices — especially the reliability of data from trials of their medicines.
Last month, the European Union banned 700 Indian-made generic drugs, citing doubts about the credibility of clinical trials carried out by GVK Biosciences, a Hyderabad-based research organisation.
Then, last week, the World Health Organisation warned Svizera Laboratories — one of four suppliers of tuberculosis drugs to its Stop TB Partnership — that inspections in July had raised “serious concerns about the integrity, reliability and accuracy of data generated and available at your manufacturing site, and on your ability to prevent contamination and cross-contamination of your products”.
“Trust has eroded so much among foreign regulators, I don’t think they take anything that’s said at face value,” warns Dinesh Thakur, the whistleblower in the Ranbaxy case, who now runs a consultancy focused on the pharmaceutical supply chain.
Nor is this a problem solely for small, obscure companies in India. Overseas regulators have been scrutinising and banning products from some of India’s biggest and most reputable groups — including Sun Pharmaceuticals, IPCA, and Wockhardt — many of which have ongoing relationships with large multinational drug companies.
Last year, growth in Indian drug exports slowed to 3%, according to the Pharmaceutical Export Council of India, a government organisation. For much of the past decade, growth had stood at a robust 12 to 13% a year.
Influential US pharmacy benefit managers, such as ExpressScripts and MerckMedco, are also increasingly concerned about their dependence on Indian suppliers — fearful that imports to the US market may be abruptly banned.
DG Shah, secretary of the Indian Pharmaceutical Alliance, an association of India’s top drug companies, acknowledges the industry is struggling to meet stringent US standards.
He says this reflects the inadequate training of lab technicians and supervisors, rather than any deliberate attempt to manipulate or falsify data by the companies’ management.
But Mr Thakur, the former whistleblower, says the problem is the lack of value that most Indians place on precision — and a general acceptance of low standards by company workers, owners and managers. “As a culture, we’ve accepted that if it meets 80 per cent of our requirements, that’s OK,” he says. “This is not a systemic pharmaceutical industry problem. This is a systemic cultural problem.”
Murali Neelakantan, former general counsel for Cipla, India’s fourth-largest drugmaker by sales, agrees that the Indian laboratory practices raising concerns among regulators have deep roots, but that it is an “organisational culture issue” for companies to train and incentivise their workers to follow global best practices, including sounding the alarm when tests point to quality problems.
“Indians as a rule don’t like to say no, and don’t like to give bad news and therefore test results always have to come out good,” he suggests. “You know what the test is supposed to say and you try to show that.”
