ISLAMABAD, June 6: Over 6,500 drugs manufactured in the country are likely to disappear from the market after this month because the federal government has not renewed their manufacturing licence to the pharmaceutical industry since December 2011.

Industry sources told Dawn that the federal health ministry used to issue NOC (no objection certificate) for ‘toll (contract) manufacturing’ of the drugs every six months but has not done so since the devolution of several federal subjects to the provinces last year.

“My company’s inventory (of drugs) would last until July. A number of other companies also are facing a similar situation,” said a pharmaceutical company representative.

“We keep stocks for up to three or four months. But since toll drugs cannot be produced without NOC, the stocks are running low and the drugs will not be available once the stocks exhaust,” said the chief executive officer of a leading pharmaceutical company.

For the last five decades, the federal government had been issuing the toll manufacturing NOC to national pharmaceutical companies twice a year, routinely and without any delay, according to him.

Toll manufacturing involves manufacturing by a third party, like national companies often manufactured drugs (tablets, syrup and injections) for multinational firms.

“The multinational companies sell their drugs with their brand names but carrying a different manufacturing name which is a global pharmaceutical industry manufacturing practice. Some 6,500 toll drugs are manufactured in Pakistan.”

A number of pharmaceutical companies, he added, had opted for toll manufacturing of drugs since it saved cost without having any impact on quality control and standard of drugs.

The names of the drugs which will be in short supply or disappear from the market from July were also provided to the chief executive officer of the newly-established Drug Regulatory Agency of Pakistan (DRAP) and its chairman, the secretary Ministry of Regulations and Services Division.

“DRAP’s head and the secretary Faridullah Khan are yet to take up the matter,” added one official.

According to a list shared by the regulations and services division’s official, a few medicines like Panadol, Oxidil injection (intra-abdominal infections and surgical prophylaxis), Flagyl (vaginal and urinary tract infections) and Benadryl (used for temporary relief from seasonal and perennial allergy symptoms) are already in short supply and will disappear in a month’s time.

A senior government official when asked about the reasons for the possible drug crisis, said: “NOC for toll manufacturing was not issued by the Cabinet Division in December 2011. The power to issue the NOC now rests with DRAP working under the newly-created Regulations and Services Division.”

Despite having powers for drug regulations, DRAP has failed to issue the NOC and its officials did not give any reason to the pharmaceutical companies.

“This is a question mark on the working of the Regulations and Services Division,” observed the official.

A local drug market survey indicated that the claim of the companies was genuine. “We have given orders but the supply is short and the prices are also fluctuating,” said Zaheer Ahmed, a local drug store owner.

He said that a number of products like Tricort injection, used in treatment of severe newborn breathing problem, was in short supply and orders were delayed by the manufacturing companies.

Mr Ahmed said other drugs like Ospexin (used for treating infections), Nicotrim (genital tract infections) and Minoderm Tablet (for treating bacterial infections) were also not available in the market.

Meanwhile, a source in DRAP said the matter was yet to be taken up by the secretary of the regulations and services division Faridullah Khan, who is also the chairman of DRAP.

When contacted, Federal Minister for Regulations and Services Division Firdaus Ashiq Awan said: “I am aware of the concerns relating to the toll manufacturing; however, we are analysing the pricing mechanism for the industry.”

She said if a multinational company was saving Rs40 to Rs50 through toll manufacturing, then the same price benefit should also go to the patients.

She said the issue would be resolved once the matter was discussed with the companies.

“I have just taken over the ministry and there are a number of issues but rest assured the matter of the toll manufacturing companies will be addressed in the upcoming meeting,” said Ms Awan.