Pharmas rush to acquire GMP ahead of new rule
PHARMACEUTICAL
companies have been rushing to acquire World Health
Organisation-General Manufacturing Practice (WHO/GMP) certification as
the Department of Drug Admini-stration (DDA) is preparing to take action
against those failing to do so. GMP certification is an assurance that
the products manufactured by a certified company are consistently
produced and controlled to meet quality standards set by the WHO. Under
this system, drug manufacturers are required to follow a standard format
during the manufacturing process to ensure the quality of their
products. Certification of WHO/GMP is mandatory to export drugs.
According to the DDA, the regulator of the pharmaceutical industry, nine
drug manufacturing companies were granted WHO/GMP certification in the
first eight months of the current fiscal year. This has brought the
number of pharmaceutical companies acquiring the certification to 33.
There are altogether 45 allopathic drug manufacturers in the country.
Among the GMP certified companies, Bhaskar Herbaceuticals, Manoj
Pharma-ceuticals and Maruti Pharma are the latest to be awarded
certification. The DDA plans to issue a Drug Manufacturing Regulation to
ensure that quality standards are met during manufacturing. “The
companies are rushing to acquire certification as we are tightening the
screw on those failing to obtain it by introducing a regulation,” said
Vijaya Laxmi Shrestha, senior pharmacist at the DDA. “The planned Drug
Manufacturing Regulation will contain a provision regarding the kind of
action to be taken against companies failing to get this certification.”
Currently, the country’s drug market is being administered by Drug
Manufacturing Code 1984. It only covers the expiry date of drugs and
their storage and misuse and dœs not deal with quality assurance of the
manufacturing process. Senior DDA pharmacist and a member of the
drafting committee Narayan Prasad Dhakal said they were introducing the
regulation to replace the Drug Manufacturing Code which will also cover
quality issues during manufacturing. According to him, the regulation
has planned to give drug makers six months from the date of enactment to
obtain certification. “If they still ignore the directive, we will take
action against them as per the Drug Act 1978,” said Dhakal. The DDA had
directed drug manufacturers to acquire certification by mid-April 2012.
However, one-fourth of the companies are still operating without it.
“In the absence of any provision regarding the action to be taken
against those not fulfilling the requirement, a new regulation has
become necessary,” said Dhakal. “Henceforth, drug companies will have to
obtain WHO/GMP or face action.” The DDA said it had started discussions
with the private sector including the Association of Pharmaceutical
Producers’ of Nepal (APPON) to give final shape to the Drug
Manufacturing Regulation.
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