1. 100% FDI has
brought new trend to unnerve the domestic pharma sector
The 100% FDI in pharma sector through automatic approval route
in new projects and investments in the existing companies only
through the approval route has prompted several acquisitions and
not given the desired result. The major acquisitions in pharma
sector have been the Daiichi Sankyo taking control of Ranbaxy Labs,
Sanofi-Aventis acquiring Shantha Biotechnics and Mylan Inc
acquiring Agila Specialties. As over 96% of the total FDI has been
into brownfield pharma projects, MNCs have so far taken control of
35% of the domestic pharma business. Seeing this trend, recently,
the Parliamentary Standing Committee of Commerce had mounted
pressure on the government, calling for a blanket ban on FDI in
existing pharma projects and putting an end to the take-over of
domestic companies by foreign players. The Health Ministry had even
suggested more stringent norms like limiting the FDI cap at 26%,
which was turned down by the DIPP.
PSA view -The objective of FDI policy is to
bring more money and allow the sector to grow further but not at
the cost of the Indian companies. India's huge domestic market
where there is no price control on patented drugs and cheap
manufacturing facilities is a great attraction to MNCs and that has
triggered this trend. If the policy continues to be implemented in
the existing manner, the access to medicine scenario in the country
could adversely impact production, availability and prices. India
could then be dependent for life-saving medicines either on
domestic facilities of MNCs or imports. India is already
import-dependent for intermediates and critical drugs like
penicillin. About 70% of India's API/intermediates are imported
2. Maharashtra FDA
makes stringent inspections at chemist shops
In the wake of increasing adverse drug reactions
("ADRs") happening in India, Maharashtra
Food and Drug Administration ("FDA")has
been conducting inspections at chemist shops in the State since
last month, to see if pharmacists are present. The FDA intends to
ensure that the pharmacists are available to monitor incorrect use
of medicines, educate patients against self-medication tendencies
and create general awareness amongst the patients. The inspections
have been so stringent that the chemist shops where pharmacists
have been found absent have to face cancellation of their license
with immediate effect. The chemists have raised their anguish
against this practice. But, the FDA is firm on its stand. Recently,
Minister of state for food and drugs administration Satej Patil made a public statement that this
practice would also be beneficial for pharmacy graduates who are
otherwise jobless. He also stated that the State is working on
establishing pharmaco vigilance machinery to ensure safe trials for
drugs and monitor ADRs.
PSA view -Self medication tendencies are very
common in India. Secondly, due to excessive commercialization,
there are times when chemists end up adopting unfair practices and
sell 'similar' formula medicines. This kind of inspection
and mandate to ensure presence of pharmacists at chemists shops to
check menace of incorrect use of medicines is laudable. It will not
be surprising to see if other states too implement this.
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