Abbott disputes regulator’s cough syrup test results

 Abbott Healthcare has challenged the West Bengal drug regulator's findings of excessive levels of codeine—a narcotic substance—in its cough syrup Phensedyl, seeking more details of testing methods, source and the trade channel from where the suspect sample of the medication was picked up. Drug regulators in West Bengal and Himachal Pradesh have charged the company's largest selling brand Phensedyl of containing excessive levels of a codeine, making the US-based Abbott the second multinational in recent months after food major Nestle to confront authorities. 

Phensedyl is valued around Rs 250 crore (MAT August 2015, AIOCD Awacs), and is around 3% of Abbott's overall sales of $1 billion in the country. It is the seventh largest top-selling medicine in the domestic retail market. Even with overall sales of just a billion, India is among the five top markets for the MNC. The company has also written to the Drug Controller General about the issue, but till now there has been no "official response'' to its communication, an Abbott spokesperson said Stock Market Trading Tips

Efforts by TOI to reach the DCGI proved futile. What makes the case complex is that there have been several instances of counterfeit versions of the cough syrup being sold earlier. 

Excessive quantity of codeine, an opium derivative, violates drug laws. In March, the drug regulator in Himachal Pradesh, where the syrup is manufactured, sent a "show-cause" notice to the company. The suspect sample which contained a higher level of codeine in the syrup was picked up and tested in West Bengal, with the drug regulator alerting its counterpart in Himachal Pradesh. Since codeine is a narcotic, its supply to companies is also controlled under law. The particular batch of 80,000 bottles was manufactured at Baddi (HP) in February last year, while the show-cause notice was served to the company only in April this year. 

The company does not feel the need for a recall of the syrup now as sales of the entire batch started in 2014 itself. Abbott said it had found nothing unusual in its own and third party testing of a retained "control sample" from the same batch of Phensedyl Himanshu Tiwari Astrologer Blog

"As soon as Abbott received information about the suspect sample, we tested a retained sample both in-house using our own method of analysis, as well as by an accredited independent laboratory. Results of both tests found that the retained sample complied with the required specifications and standards, including the codeine content. We therefore remain confident in the quality of our product," the company spokesperson said. It is not known whether the sample of Phensedyl was a genuine product or a fake one, as it is understood to have been picked up from near the border in West Bengal. Over the years, there have been several instances of cough syrups like Phensedyl and Corex being misused as they contain codeine, which gives a "high''. 

Recently, the company was reportedly in the dock in Hyderabad for smuggling Rs 57.6 crore worth cough syrup containing narcotic components into Bangladesh using fake bills. 

"Abbott has requested the State Drug Controller to provide more information about the source of the suspect sample and the manner in which it was collected, to establish whether the sample was collected from genuine trade channels through proper process under the Drugs and Cosmetics Act", the company official added Indian stock market astrology prediction

This latest case of Abbott exposes the cracks in India's unwieldy and poorly-resourced drug and food regulatory system, where quality is rarely monitored, creating a potential risk to consumers. 

Even the distribution system is not proper, leading to adulteration in many pills, insulins and vaccines in the absence of a cooling chain. 

In May this year, the Uttar Pradesh Food Safety and Drug Administration had asked Nestle Indiato withdraw a batch of popular Maggi noodles from the market after it was reportedly found to contain high levels of lead. A controversy erupted with conflicting reports from state food regulators, leading to Maggi being taken off the shelves and prompting several states to ban the 'two-minute' noodles Commodity Market Astrology Tips