July 18, 2006	Tuesday	Jumadi-ul-Sani 21, 1427

Please Visit our Sponsor (Ads open in separate window).

ISLAMABAD, July 17: A six-member committee was formed here Saturday to resolve a controversy regarding recall of expired medicines from the market despite Supreme Court directions to destroy spurious and expired medicines available on the shelf.

Presided over by Health Minister Mohammad Nasir Khan, a high-level meeting reviewed reports of different pharmaceutical companies submitted in line with the May 12, 2006 directions of the Supreme Court to ensure that all expired medicines in the market were destroyed.

During the meeting, Arshad Awan of the Pakistan Chemists and Druggist Association (PCDA) appreciated recall of 80 per cent expired medicines from the market by different manufacturers, but deplored that still there was a leftover of 20 per cent which should also be removed immediately.

Multinational companies, however, disputed the statement, but on the suggestion of the drug controller, the six-member committee was constituted to look into the matter and resolve the controversy.

The newly-formed committee will comprise Dr Iqbal Somroo (PCDA), Riaz Hussain (Pharma Bureau), Mohammad Usman of the Pakistan Pharmaceutical Manufacturers Association (PPMA), Shaukat Sindu of the Pakistan Pharmaceutical Importers Association (PPIA), Naser Qureshi of the Rawalpindi, Islamabad and Hattar Manufacturers Association, and Arshad Awan of PCDA.

PCDA will collect evidence from their members after which the committee will reach the conclusion next week.

PCDA representative said his organization had been complaining continuously as few pharmaceutical firms had refused to recall the expired medicines on the grounds that such medicines were without warranties or the expired stocks had been laying with the chemists or wholesalers for years.

Pharma Bureau argued that their member companies had recalled expired medicines worth Rs162.54 million from the market and had destroyed them as per the prescribed manner.

Stocks have been collected from retailers and wholesalers who have shown warranties and receipts of purchase.

The bureau, however, took the stance that action should also be initiated against retailers or wholesalers who did not possess warranty invoice, but were claiming for the replacement of expired stocks.

Meanwhile, a draft mechanism has also been proposed by the health ministry to give a legislative support without creating any dispute over the recall of substandard/spurious/adulterated/misbranded and expired drugs from the market.

Under the new rules, manufacturers and importers are required to establish an internal mechanism for quality assessment throughout the shelf life of a drug after marketing.

In case defects are identified through their internal assessment system in any batch of the drug, these would be recalled immediately, the notices of which would also be published in newspapers.

Manufacturers will also recall unutilised quantity of a drug from the market immediately if any batch of such a medicine was declared spurious/substandard/adulterated or misbranded by the drug testing laboratory.

However the manufacturers can utilise the recalled stocks of the drug if subsequently passed by appellate laboratory.

In case the drug is declared substandard or adulterated by the appellate laboratory also, the recalled stocks will be destroyed by a committee constituted by the provincial or federal governments.

Manufacturer, importer or indenter will also collect the soon-to-be expired drugs from the market before expiry date. Besides, 100 per cent compensation will be given to the purchasers if intimation on a prescribed form is given in writing to the manufacturers, indenters or importers three month prior to expiry date.

Likewise, 50 per cent compensation will be given to the purchasers if intimation is given one month prior to the expiry date, while 25 per cent will be given if intimation is forwarded one day prior to the expiry date.

Retailer or distributors/wholesalers who failed to intimate the manufacturer or indenters directly in writing or through their authorised agents in the prescribed manner and possessed any expired drugs will be held responsible and liable to be proceeded against in accordance with law.

Mohammad Nasir Khan, during the meeting, emphasised that it was the moral and legal duty of the government that no spurious or outdated drugs should be placed on shelves. “Such a practice reflects bad impression at the international level,” he said.