Panel to investigate pharma firms red-listed by Vietnam
CDSCO plans to rope in state drug
control organizations to look into the issues raised by Vietnam over the
quality of drugs from India
Close on the heels of Prime Minister Narendra
Modi’s visit to Vietnam to “strengthen bilateral ties, including defence,
security and trade”, the ministry of commerce and industries is planning to set
up a committee, along with the Central Drugs Standard Control Organization
(CDSCO), to inspect Indian pharmaceutical companies which have been banned from
Vietnam for exporting sub-standard drugs.
CDSCO plans to rope in state drug control
organizations to look into the issues raised by Vietnam over the quality of
drugs from India.
Manufacturing practices of over 50 pharma
companies are potentially suspect as they were “red-listed” for regulatory
non-compliance by the Drug Regulatory Authority of Vietnam in 2014.
The companies which were red-listed included Strides Arcolab
Ltd, Medley Pharmaceuticals Ltd, Marck Biosciences Ltd, Marksans Pharma Ltd and
Umedica Laboratories Pvt. Ltd.
“The ministry of commerce has initiated
discussions with us about looking into the manufacturing practices of Indian
pharmaceutical companies red-listed by Vietnam. We are at the initial stages of
the development,” an official from the CDSCO said, requesting anonymity.
Queries emailed to the ministry of commerce
and CDSCO went unanswered.
Last year, the CDSCO and Pharmaceutical Export
Promotion Council of India (Pharmexcil) had held a strategic meeting with their
Vietnamese counterparts to assuage concerns being raised about the safety of
Indian drugs.
“Repeated questions about the manufacturing
standards and regulatory compliance of Indian pharmaceutical industry can
damage the country’s stature as a global drugs exporter. If the complaints are
genuine, the state drug regulating authorities may suspend or cancel the
licenses of the errant companies,” another official from CDSCO said, also
declining to be named.
The commerce ministry may also cancel or
suspend the Import Export (IE) code of the companies, depending on the
inquiry’s conclusion, said the first official cited earlier.
The IE code is a registration issued by the
Directorate General of Foreign Trade and is required for importing or exporting
goods and services from India.
Suspension and cancellation of the IE code
could be done, as per the Foreign Trade (Development and Regulation) Act, on
the grounds “that any person has made an export or import in a manner gravely
prejudicial to the trade relations of India with any foreign country or to the
interests of other persons engaged in imports or exports or has brought
disrepute to the credit or the goods of the country.”
Industry analysts believe that while
compliance and manufacturing practices of Indian pharmaceutical companies are
getting better, the government must act against, and address systemic failures
by companies.
“The perception of India as a safe generic
drugs exporter should not suffer. While issues are bound to crop up, there
should be no compromise on the safety and quality of drugs being exported.
Failure by pharmaceutical companies to adhere to regulatory norms should not be
treated by the government as simply a particular company’s issue,” said
Muralidharan Nair, Partner – Life Sciences, E&Y.
A significant chunk of Vietnam’s
pharmaceutical market comprises of generic drugs, with India being a
significant exporter.
Industry estimates peg the overall market
size at over $2.6 billion and expected to hit $8 billion by 2020.
In recent years, however, Indian
pharmaceutical product exports to the Vietnamese market have dipped
significantly, reflecting the effects of the ban. According to official
commerce ministry data, exports fell 12% to $146 million in 2015-16 from $165
million in the previous fiscal year.
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