The recalling of medicines and edibles in case of contamination is common in developed countries but is rare in Pakistan as health and safety guidelines are rarely followed here.

“I have been working as head of the Drug Regulatory Authority of Pakistan (Drap) for almost three years and during this time, I do not remember an instance where a company has voluntarily recalled medicines or other edibles from the market. This shows that companies have been working responsibly and the quality of drugs in Pakistan is also satisfactory,” said Drap Chief Executive Officer Dr Mohammad Aslam.

However, many officers in the authority do not agree with him and said the fact that companies which do not voluntarily withdraw their products from the market does not mean they are producing quality medicines.

“The population of the US is almost 300 million and there are 200 million people in Pakistan but the same amount of medicines are consumed in both countries. Approximately 190 million litres of intravenous fluids are administered to patients in the US every year and one million litres are recalled,” a Drap official told Dawn.

“Metal particles, fibre and glass particles, silicon fragments and insect parts have been found in the recalled products in the US,” he added.

The officer said the technology and monitoring system is far more advanced in the US than in Pakistan and that the only reason drugs are not recalled here is not because of their superior quality but because contaminated and impure IV fluids and medicines are given to patients and no one takes notice.

“I can for sure say that medicines are being administered without any checks. Mock recalls are also held every year in the US to see how much time a company will need to collect its medicines from the market and ensure the safety of consumers,” he said.

On Dec 17, 2017, Drap issued a statement saying it has stopped the marketing of contaminated baby formula. The statement said that Drap has issued a public advisory regarding the use of Celia and Gromore, product of Lactalis International, France due to the global recall of a few affected batches by the principal manufacturer and importers as informed by the World Health Organisation (WHO).

“These particular batches of Celia and Gromore being voluntary recalled were recommended for use in lactose intolerant infants. Pursuant to the global recall, Drap has taken prompt action and activated the Federal Inspectorate and Quality Assurance team for the removal of implicated batches from the market,” the advisory states.

“Drap has collected the records of import transaction of these batches from France. The recall process has been initiated in collaboration with the provincial governments of Punjab, Sindh, Khyber Pakhtunkhwa, Balochistan, Gilgit-Baltistan, AJK and ICT administration, who were advised to monitor the recall process through their surveillance force,” it said.

However, Drap officials said the French government has declared the baby formula in question as harmful as it contains highly sensitive bacteria that can cause prolonged diarrhoea and abdomen-related diseases in infants. The French government ordered the manufacturers to recall all consignments from across the globe and pay compensation to its consumers, most of which are in seven countries including Pakistan.

The French government took action on Dec 1 and this was widely reported in international media but the product continued to be marketed in Pakistan till Dec 13.

Drap CEO Dr Aslam said companies had started recalling the product voluntarily but Drap also played an important role.

“Unfortunately, some products like powder milk are in the grey area and are sold as food supplements and not medicines which is why it is sometimes difficult to take action against them. If the milk is boiled for two minutes, it would become bacteria free,” he said.

Dr Aslam said the milk was recalled voluntarily in some countries and on WHO directions in others.

Federal Drug Inspector Dr Obaid Ali had on Dec 15 written a letter, available with Dawn, to Drap and the Ministry of National Health Services suggesting that a public advisory on this matter be issued.

Talking to Dawn, Dr Obaid said the French government had told the company to hold a press conference and announce global recall and also announce that consumers will be compensated. International recall was started from Dec 1 but no one took notice of the matter in Pakistan. Marketing companies contacted Drap on Dec 13, when the matter was discussed in international media, and said they will recall the milk voluntarily, he said.

“Some advertisements were published but they were vague and the names of the two marketing companies were also not mentioned and consumers cannot, therefore, contact the companies for compensation. In other countries, usually commissions are established during such events to ensure consumers receive compensation but there is no such trend in Pakistan,” Dr Obaid said.

Hardly any big recalls are made in Pakistan. A large company which is marketing its own products in Pakistan announced to recall five million containers of baby formula in Sept 2010 due to possible contamination with insect parts or larvae.

Published in Dawn, January 14th, 2018