Indian drug companies blame Modi Govt for thwarting licences to sell generic medicines
The Narendra Modi government has come in for
sharp criticism from some in the Indian pharmaceuticals industry over its
policy on the production of generic drugs in India that has been perceived as
favouring U.S. drugmakers over Indian ones, and as being directly contradictory
to the prime minister's Make in India campaign.
Lee Pharma, a Hyderabad-based mid-sized drug
company, said Thursday that the Drug Controller General of India (DCGI) did not
allow it to sell cheaper and generic versions of a diabetic drug possibly due
to the Modi government's assurance to U.S. pharma companies over the issue of
protecting intellectual property rights (IPRs). The company had applied for a
compulsory licence from the DCGI last year to produce a cheaper, generic
version of the diabetes medicine saxagliptin, made by global pharma firm
AstraZeneca.
"The DCGI rejected our application for
the second time this year although we covered all the necessary grounds made
mandatory by the drug regulator," Lee Pharma's Patent Attorney Afzal
Hassan told International Business Times, India on Thursday. "The DCGI
last year in one of the hearings said it would go back to seek the views of the
commerce ministry .The application, however, was rejected this year," he
said.
According to Hassan, the company had
fulfilled the legal criteria to obtain the licence under the Bombay High
Court's 2014 ruling in favour of NATCO Pharma, which was the first Indian
company to apply for such a permit. Hassan also said that the rejection of Lee
Pharma's application could be a fallout of Modi's commitment to U.S.-based
pharma companies over the issue of protecting their IPR.
During Modi's visit to the U.S. in September,
the prime minister reportedly told a gathering of companies in New York that
India is "committed to protecting IPR which is essential to fostering
creativity." Earlier, in May, the U.S. placed India, along with China, on
a list of countries that fail to protect IPR, NDTV reported.
Another Indian pharma company, which sought
compulsory licence to sell the generic version of the cancer drug dasatinib,
originally manufactured by Bristol-Myers Squibb, said it would no longer pursue
the case. BD Pharma had proposed to sell the cancer drug at $122 for a month's
course compared to the original price of about $2,491 -- a bid rejected by the
Indian government three years ago.
"There is no point in pursuing it
anymore," Dharmesh Shah, BDR's managing director, was quoted as saying by
Reuters.
The two mid-sized drug companies told Reuters
that the Modi government's drive to boost foreign direct investment in India by
protecting IPRs may have come in the way of procuring the mandatory licences.
Meanwhile, Medecins Sans Frontieres (MSF) or
Doctors without Borders was quoted by STAT News as saying that any effort by
the Indian government to curtail the production of cheaper versions of drugs is
bound to affect patients not only in India but elsewhere in the world as well.
"We don't have full details from the
companies, but we think this may be a case of external pressure placed on India
through bilateral discussions with the United States," Yuan Qiong Hu, a
legal and policy advisor with the Access to Medicines campaign at MSF, was
quoted as saying by STAT News.
MSF had said in March, ahead of the EU-India
summit, that Modi should not succumb to pressure from the EU over IPR issues,
which could potentially block the access of millions of people globally to
cheap medicines.
While the union commerce ministry told
Reuters there was no change in its policy to promote manufacturing in the
country, the Modi government's move to deny licences to these pharmaceutical
companies for the production of generic drugs is being seen to be in direct
contrast to his "Make in India" campaign, which aims to create jobs
and boost the Indian economy by creating a good environment for manufacturing
practices in India.
Source: http://www.ibtimes.co.in/indian-drug-companies-blame-modi-govt-thwarting-licences-sell-generic-medicines-674633
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