Over 10 drug manufacturers have recorded two or more incidents of quality failures in 2012 and 2013, with some pharmaceutical companies guilty of more than seven to eight quality failures. In the last year alone there have been over 100 recorded cases of quality failures, while this year the number exceeds 70 cases by end [...]


Drug Regulatory Authority prefers ‘pain killers’ to prevention and cure

Substandard drugs abound despite repeated quality failures for want of stringent deterrent measures

Over 10 drug manufacturers have recorded two or more incidents of quality failures in 2012 and 2013, with some pharmaceutical companies guilty of more than seven to eight quality failures. In the last year alone there have been over 100 recorded cases of quality failures, while this year the number exceeds 70 cases by end August.

However, the Cosmetics, Devices and Drug Regulatory Authority (CDDRA) is yet to take action against some of the quality failing manufacturers. CDDRA Director Dr H. Beneragama said he is still waiting for the report on drug manufacturers who have failed to meet quality standards on multiple occasions.

“I have commissioned a report on all drug companies which had multiple quality failures. Once the report is completed, I will be able to take action,” he said. In an attempt to arrest the deteriorating trend of the pharmaceutical drug sector in the country, last week, the CDDRA banned four drug companies, namely, Elysium Pharmaceuticals, India, Bafna Pharmaceuticals, India, Vivek Pharmachem, India, Laborate Pharmaceuticals, India, which have been supplying the local pharmaceutical market with 122 varieties of drugs.

According to CDDRA Director Dr H. Beneragama, these companies were blacklisted and have been informed to recall all their drugs supplied to the market with immediate affect, due to continuous failure to comply with quality standards stipulated by the Authority. The companies blacklisted also supplied drugs to the State Pharmaceuticals Corporation (SPC) which procures pharmaceutical items for the government hospital system, including drugs used for treating cardiac and diabetic patients.

According to data available on quality failures of pharmaceutical drugs in the last year alone, Elysium Pharmaceuticals has recorded nine incidents of failure to meet quality standards, while there had been five such incidents including a total product recall in 2013. Vivek Pharmachem had recorded a total of two quality failures, Laborate Pharmaceuticals recorded three and Bafna Pharmaceuticals recorded two such incidents in 2012 and 2013.

When asked why there has been a lapse of over 8 months to take action against companies which have failed to meet quality standards continuously, Dr Beneragama said that the regulatory system is still being fine-tuned.

If you look at the quality issues of these companies, there had been many, and that is the main reason to ban these companies.
If you look at the last so many years, the action taken against such companies is much less than what is happening now. But just because something was not properly done in the past, doesn’t mean that we should wait. In the recent past, we have decided to take stern action, banning the company with multiple quality failures, for a period of four years.

Anyway, if you review past guidelines, when one batch fails, the procedure is to remove that particular batch, when five batches fail, we withdraw the product, and that was the end of the story, then the registration existed. But now we have decided that, when a number of quality failures are reported within a short period of time, we will ban the company, and of course, if they wish to re-enter the market, they have to improve,” he told the Sunday Times.

When asked why the Authority has not taken preventive action when a trend in failure to comply with standards are displayed by some companies, and carry out further tests to ensure quality standards are met on the drugs supplied by such companies, Dr Beneragama denied any lapse on the part of the authority and the National Drug Quality Assurance Lab (NDQAL) which is responsible for post-market testing.

“This has been done by the drug quality assurance laboratory, which are there to carry out post-marketing tests. When a quality failure is reported, then we call the manufacturer and the procurement agent in the SPC, Food and Drug inspectors and other officers in the country, therefore they are vigilant. The NDQAL is supposed to do random checks on samples,” he said.

According to Dr Beneragama, the network of officers spread islandwide would ensure that all 122 products are withdrawn from the market, although which specific products have been supplied to the market out of the total of 122, is not readily available. Further, CDDRA is also not aware of the quantities of the products available in the market, making it difficult to predict a shortage of the drugs or not.

However according to data available through the CDDRA, Star Drugs and Research Labs, India, has recorded seven such quality failures from January 2012 to August 2013, and drugs supplied by Satallion Laboratories Pvt has recorded four such incidents. Further, Dr Beneragama told the Sunday Times that Central Drug and Pharmaceuticals, Chennai, and Apurva Biopharm Inc have been blacklisted earlier this year. However, quality failures of drugs supplied by these companies have been recorded throughout this year, with the last incident being the quality failure of Oxytocin Injection 5IU supplied by Apurva Biopharm, India, in July this year. The Sunday Times was unable to obtain a clarification from Dr Beneragama as he did not answer his phone.

Speaking on the issue, Government Medical Officers Association (GMOA) President Dr Anuruddha Padeniya dismissed the decision to be a mere “Media Show”, stating that the authority should take firm action against such violations, without just blacklisting such companies.

“If I put harmful chemicals in fruits and sell, then I wouldn’t be just asked to stop selling the fruits, legal action would be taken against me. It should be the same in this case” he said. Dr Padeniya also said that these companies will enter the market again by registering under a new company name, which makes it impossible to regulate the pharmaceutical industry.

He further pointed out that the country does not have a single drug information centre for the public to access information on drugs. “We don’t have a way of finding out if the drugs are registered or not, we are still in the dark. The list is still being drafted. Today technology is so sound that any good pharmacy can tell you the availability of a drug by clicking a button, but the ministry is not able to tell us what is available in the market. There is no transparency at all,” Dr. Padeniya said, pointing out that the Ministry of Health should act promptly and make the updated lists available.

According to him, the Ministry has stated that it is unable to print the registered drugs list due to high costs but have agreed to upload the website. The list of registered drugs does not clearly indicate the drugs supplied by the four blacklisted companies, while the website informed of only three blacklisted companies through its circulars. The website does not carry the full list of quality failures and displays only up to January 2013, although 70 more quality failures have occurred since then. The list of product recalls only records the incidents in 2011, while in 2013 itself there had been over 10 product withdrawals.

However, Dr Beneragama stated that the CDDRA website is one of the key reference points for the public to learn about quality failures in drugs, as no other measures are taken to inform the public of such issues. “We cannot inform all 20 million citizens of the country, it is their duty to seek out the information. Our website will carry the information, and inform the network of officers responsible to ensure that the drugs are removed from the market.

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