[india-drug] Schedule H drugs could be shifted to OTC

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

(Source: http://www.pharmabiz.com/article/detnews.asp?articleid=19779
thanks

Pharmacy oriented participants could stimulate this discussion for the
clinicians to join in, regarding  Schedule H drugs and if we are ready
in India to shift to the OTC drugs keeping in mind the state of ADR
monitoring in India. Unequal comparisons of the status of drugs in USA
versus India are not well justified. It is a well-established truth
that in USA the drugs that gets banned and pulled voluntarily out of
the profitable market due to stringent post marketing surveillance is
not what happens in India. We continue to use a lot of drugs in our
country that have been banned outside??..what happens to these
comparisons in such unequal situations? 
Looking forward to initiation of a discussion. Thanks?..SS)  


Some drugs under Schedule H could be shifted to OTC: Dr MD Nair
---------------------------------------------------------------
Wednesday, January 07, 2004 08:00 IST 
Our Bureau, Chennai

The government should bring in necessary legislations to periodically
review the Schedule H drugs, and some could be made available as OTC
drugs, according to Dr MD Nair, member of the Mashelkar Committee and
senior pharma consultant. 

At present, numerous drugs that have proved its efficacy and safety are
available in the country. Schedule H could be reviewed from time to
time depending on usage, quality and safety profile with flexibility in
the existing system to promote sale and distribution of certain drugs.
For example, ranitidine is an OTC product in USA, while it is still a
prescription drug in India. 

The existing arrangement for post marketing surveillance lacks
necessary teeth. Reports on efficacy and safety are normally privy to
the manufacturers, and independent studies and reports are rare. Even
many doctors lack enough knowledge on side effects of drugs. Due to
various reasons, Adverse Drug Reaction (ADR) reporting has not become
an effective tool for surveillance. 

Therefore, it is necessary to develop a protocol with necessary
provisions to constantly evaluate drugs in the market and a better
mechanism is required for ADR reporting. It is also important to
evaluate the extent of infrastructure and availability of monitoring
mechanism for post marketing surveillance. This should be part of our
overall healthcare marketing policies, said Dr Nair, in an interview
with Pharmabiz.

He noted that while the United States has a separate legislation for
nutraceuticals in the form of GISHA, India is yet to develop a
nutraceutical policy. As per the existing provisions, it was impossible
to book companies selling vitamins or similar products as food
supplements, noted Dr Nair.


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