DRAP ‘fails’ in seizing supply of expired medicines

Islamabad - The Drug Regulatory Authority of Pakistan (DRAP) has failed to seize expired medicines, which were exposed to extreme temperature and later supplied to the market, an official said on Wednesday.

The Karachi-based Federal Inspector of Drugs (FID) wrote a letter to the Ministry of National Health Services (NHS) asking for an immediate action by recalling the medicines from Sindh’s rural area, as the medicines had been exposed to extreme temperature for around 45 days.

The letter available with The Nation stated that the issue is pending since July and expired medicines are being supplied t the market owing to DRAP’s silence.

Despite of several reminders to the federal authority, no action has been taken to secure or recall the expired medicine from the market.

“It is just for the record that none of the officers of DRAP has so far contacted the office of undersigned for any advice, direction or pursuance even upon several formal requests,” the letter said.

The letter further stated, “It is a matter of safety and health of the public at large. The procedure of DRAP to pick up drug samples and get them tested from CDL is highly questionable as long as drug products have been exposed to extreme temperature.

In this way, DRAP allowed the continuation of consumption of the drugs that otherwise may harm the consumers. All duty-bound necessary actions are requested to ensure the bottom line i.e. assurance of availability of quality and safe drugs for fellow citizens.”

“As investigation is open, this office requires coordination from the office of Drug Control Administration, Karachi for the names of companies that supplied medicines to the PPHI and central licensing Board, Islamabad to get names of qualified persons of those companies and their CNIC cards for onward proceedings on the matter under the Drugs Act 1976 and DRAP Act 2012,” it says.

Talking to The Nation, Federal Inspector of Drugs Obaid Ali said that government has given Peoples Primary Health Initiative (PPHI), a non-governmental organization, the contract of storing the medicines.

He said the condition of the medicines in the warehouses has gone worse due to extreme hot weather.

“The medicines worth million of rupees, and are being supplied to the rural areas,” he said.  He also said that the federal authorities were contacted multiple times to take action against the organisation by constituting a committee but all in vain.  Earlier, Pharma Bureau had also written a letter to the health ministry claiming that Federal Inspector of Drugs Obaid Ali had warned of strict action against PPHI including seizure of their products and initiating regularity action. He also accused them of quality failure.

The letter states, “Please note that our member companies have been supplying PPHI, the customer, with quality products after fulfilling all GMP and GDP requirements. PPHI has a DRAP approved warehouse fulfilling and meeting the criteria of product storage conditions. It is the responsibility of Area FDI and PPHI, itself to maintain proper storage conditions, as laid out by DRAP when issuing a license to the premises.”

DRAP Chief Dr Aslam Afghani talking to The Nation said that federal authority awards the license of drug storage and supply in the market to the company after a legal procedure.  He said, later on, it is the responsibility of provincial authority and relevant drug inspector to check and report any negligence.  The official was reluctant to comment on the worth and current condition of the medicines.

A senior official at NHS wishing anonymity also said that DRAP and the official are at loggerheads with each other because of some departmental inquires.  The official said that it is FID’s responsibility to take proper legal action by taking samples and sending it to the lab to confirm the expiry of medicine. The ministry has been written a letter but no legal action has been taken by the inspector, said the official.

 

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