66,000 drugs registered under Drug Act 1976

ISLAMABAD – As much as 66,000 drugs have been registered in the country by December 2010, 55,000 of them as active drugs, under Drug Act 1976. According to Pakistan Pharmaceutical Manufacturers’ Association (PPMA) Chairman Haroon Qasim, around 10,000 are imported drugs while about 1,000 drugs have been de-registered over the last many years for several reasons like international withdrawals, safety recalls etc.
In a statement, he said the registered drugs included medical disposable devices such as disposable syringes, catheters, bandages etc. “As such there are approximately 55,000 active drug registrations,” he added. Referring to Drug Registration Board meetings, Qasim said only 6 meetings took place in the year 2010.
The process of registration of drugs is a tedious task and it takes approximately 8 to 12 months for the Health Ministry to complete the evaluation of submitted dossiers to ensure that nothing is missing and all rules have been complied with before the drug registration dossier reaches the drug registration board for registration.
In many instances the facility inspections are done, stability studies are taken and there are numerous rules and regulations which are taken into consideration by the ministry, Qasim noted. The PPMA chairman said the drug registration board is a competent board, having experts from all the fields, including officials from the Health Ministry and provincial health officials, professors from academic institutions, medical doctors, consumer associations and a few others to ensure that the registration process was fully complied.
“Though PPMA has its representation on the board, it is not as a member but just as an observer,” he said. “Therefore, it is not fair to say that the PPMA can pressurise the Ministry of Health for drug registration,” he added.