Pakistan: Wrong labelling on children’s drugs: Pharmacists call for lifting entire stock of Phenergan, Flagyl

http://www.dailytimes.com.pk/

Flagyl suspension (meteronidazole) for children was supplied to market in bottles, which actually contained Phenergan (promethazine). The manufacturers, Messrs Sanofi Aventis, and the DRAP remained silent on the issue for a long time. A patient did file a complaint with the Pakistan office of Sanofi and also with its Europe office. The Europe office, however, ordered its officials in Pakistan to take action within 24 hours.

Outer cartons of Phenergan 120ml, the primary label is of Flagyl Suspension 90ml. However, the bottle actually contains Phenergan – a drug which has been declared spurious under Section 3 of the Drugs Act, 1976. Since, it is a gross failure; rather worst failure than Efroze tragedy in which hundreds of patients died in the Punjab Institute of Cardiology due to supply of adulterated/contaminated medicines in 2012. The mix-up of material requires laboratory testing while in this case, naked eye could have caught the wrong labelling.

In outer cartons of Phenergan 120ml, the primary label is of Flagyl Suspension 90ml. However, the bottle actually contains Phenergan – a drug which has been declared spurious under Section 3 of the Drugs Act, 1976. Since, it is a gross failure; rather worst failure than Efroze tragedy in which hundreds of patients died in the Punjab Institute of Cardiology due to supply of adulterated/contaminated medicines in 2012. The mix-up of material requires laboratory testing while in this case, naked eye could have caught the wrong labelling.

The Pakistan Pharmacists Association President Dr Nabeela Latif said said that medicine manufactured by Efroze was not spurious but a case under Section 302 of the Pakistan Penal Code (PPC) was registered and factory was sealed. Then came the case of Tyno syrup, where medicine was not spurious or adulterated but not only a criminal case was made against the company, Messrs Reko Pharmaceuticals, its factory was also closed down. Another case of Messrs Orient Laboratories, which was not of any mistake in medicine manufacturing but of negligence in factory, was also prosecuted under Section 302 of the PPC. She added that the common man could not understand how labels of Flagyl 90 ml bottle were pasted on bottle of Phenergan 120ml syrup. This fiasco has the potential to create medical emergencies, especially if a child required meteronidazole but was treated with promethazine, she said.

She said that the company gave an advertisement in national newspapers for recall of a certain batch number whereas our common patient is not very well aware of batch numbers and that it is also not necessary that every patient had read the advertisement. So, she said, it was essential that company must lift entire stock of Phenergan and Flagyl from market and supply fresh stocks without delay. Moreover, she said, the company started Flagyl’s promotional advertisements on radio without obtaining approval from any regulatory agency; while the regulator is in a deep slumber especially when Flagyl is not over-the-counter drug and is sold only upon furnishing a prescription.

She said that the company had delivered over 200,000 bottles of these syrups across the country in December 2013 but that only 6,000 bottles of one batch were recalled. She said that nobody knows that how many children have lost their lives or suffered different medical complications after using these wrongly labelled and spurious drugs.

She said that law-enforcement agencies have dealt local companies with an iron fist but that they are silent when a multinational had produced spurious drug, which was sheer discrimination.