500 drug products await registration
ISLAMABAD, Aug 16: Registration of over 500 drug products is pending with the federal government since an approval is still awaited from the cabinet division, it was learnt on Tuesday.
According to a senior federal government official close to the development, around 47 companies have applied for registration of several products already approved by the drug registration board. However, the cabinet secretary is yet to issue a notification in this regard.
The official said a drug registration meeting was held at the cabinet division on Aug 2.
The minutes of the registration board meeting were also approved but a notification approving the registration of the said products was not issued, creating hardship for several drug manufacturers.
An industrialist requesting not to be named told Dawn that around Rs12 billion investment remained stuck because of the delay in the process by the federal government.
He added: “We cannot initiate production of drugs till we get the registration licence.”
He said registration of some 14,000 products had been pending for years while the cabinet secretary had given approval to only 500 products.
“The 47 drug companies were issued drug manufacturing licences after they fulfilled all the prerequisites for drug manufacturing but registration of over 500 products is still pending, which adds to our investment losses,” he observed.
He said besides the 47 firms, around 75 drug companies were also looking for `new sections` of drug registration. Drug companies, which were already manufacturing products like syrup and additionally looking for registration of pills, were attributed under the tagline of the new sections.
When contacted, Cabinet Secretary Nargis Sethi said: “I want to be very very careful regarding registration of drugs because it is a sensitive issue. I don`t want to issue licences which in a later stage can become a headache for anyone.”
The official insisted that there was no delay at all in the filing system at her division. Only caution is duly exercised for registration of any new drug because there was a lot of hue and cry over the same issue some time back, she added.
She said the matter was not supposed to come to her and instead was to be resolved at some lower level. “But I am reviewing it myself to maintain transparency.”
Ms Sethi said since there was no permanent institution after the devolution of federal health ministry to look after such concerns, she was as careful as one can be.