Government report reveals weak spots in functioning of Indian pharma industry (Pharma Industry ,GS paper 3 ,DTE )

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Staff crunch, transparency issues and outdated trial methods plague monitoring activity

To bring about transparency, digitalisation of clinical trials has been recommended by the government task force (Credit: Taki Steve/Flickr)To
bring about transparency, digitalisation of clinical trials has been
recommended by the government task force (Credit: Taki Steve/Flickr)

A latest government report shows that India suffers from poor
monitoring quality when it comes to drug inspection due to the lack of
adequate staff.

The Central Drugs Standard Control Organization (CDSCO), which
regulates the import of medicines in the country and gives approval to
new drugs and clinical trials, has only 340 sanctioned posts.

This is compared to the 13,000 sanctioned posts comprising technical
as well as administrative staff of the US Food and Drug Administration
(USFDA). The CDSCO also conducts meetings of the Drugs Consultative
Committee (DCC) and the Drugs Technical Advisory Board (DTAB).

The irony is that of these 340 posts, only a few have been filled up
so far, reveals a task force report released on Monday. It was set up to
give suggestions on the future growth of the Indian pharmaceutical
industry. The task force was constituted by the Ministry of Chemicals
and Fertilizers, Government of India, in 2014.

More drug inspectors needed

The number of foot soldiers is very few, according to the report.
India needs at least 3,200 drug inspectors, but has only 1,349
sanctioned posts at present. Of this, 500 posts are lying vacant.

The report says that drug inspectors should be recruited for
effective monitoring of various drug manufacturing units and
distribution outlets. There should be one drug inspector each to look
after 50 such units and monitor distribution outlets. There are
approximately 600,000 drug retail sales outlets and around 10,500 drug
manufacturing units across the country.

Transparency, drug pricing

As far as transparency in clinical trials is concerned, the task
force has recommended the digitalisation of clinical trials. The report
says trials, licensing and quality control need to be computerised and
made available online to expedite the process.

Besides, the ministry also favours the creation of a single window
medicine monitoring IT system to link the headquarters, respective state
offices and government hospitals for smooth communication.

The task force report also gives suggestions on effective price
control. It says that there is a need to review the implementation of
Drug Price Control Order (DPCO), 2013 to resolve the problems of
implementation. This is a notification-cum-order which empowers the
National Pharmaceutical Pricing Authority (NPPA) to regulate the prices
of essential drugs. The DPCO suggests that the government should
implement price control mechanisms through a consultative approach.

The report has been prepared after consulting private players and the
issue of accessibility of drugs to the masses has been largely
overlooked, the ministry says. Industries have challenged all efforts to
minimise the prices of essential medicines.

The civil society has also raised the issue, claiming that the
existing mechanism does not make essential drugs accessible to the poor
and that drug manufacturing companies are still making huge profits on
their products.

Government’s stand

While releasing the report, Union Minister of Chemicals and
Fertilizers Ananth Kumar said that the government wanted to encourage a
robust pharmaceutical industry in the country that is standardised,
innovative and competitive.

Setting up the task force was one of the major initiatives of the
Centre, he added. According to the minister, the government is keen on
the early implementation of the recommendations of the task force and it
would come out with an action-taken report based on these
recommendations in 100 days.

Secretary of the Department of Pharmaceuticals V K Subburaj said
exports by Indian pharmaceutical companies was a successful venture.
However, regulations in this sector, are weak and it is affecting
further growth, he added.

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