The Union health ministry has started the process of further amendments
to the Drugs and Cosmetics Act to streamline the rules in the clinical
trials and medical devices segment in the country. Redrafting of the
D&C Act in this regard is in an advanced stage and the ministry
proposes to introduce the amendments in the next session of Parliament
for its final nod, it is learnt.

Sources in the health ministry,
who are involved in the redrafting process, said that the entire process
is being done by the ministry according to the recommendation of the
Mashelkar Committee, which had recommended an overhaul in the Act to
make it more effective. Apart from other administrative changes like the
creation of a Central Drug Authority (CDA), the Mashelkar committee had
recommended to the government to make the punishment for manufacturing
and marketing of spurious drugs more stringent.

The Union health
ministry had already amended the D &C Act to make punishment part
more stringent. The Drugs and Cosmetics (Amendment) Bill, better known
as Spurious Drugs Act, was passed by Parliament in October 2008 and it
received President's assent in December same year. The union health
ministry on August 10, 2009 had notified the Drugs Act Amendment Bill,
enhancing the punishment to 10 years imprisonment and a fine of Rs.
10 lakh for production and sale of spurious drugs. Under the new
amendment in the Act, production and sale of spurious drug was made a
non-bailable offence.

After making the punishment part of the Act
more stringent, now the ministry wanted to bring the segments like
clinical trials and medical devices under its ambit for further
streamlining the regulations. The development is part of a series of
measures being undertaken by ministry to strengthen regulatory
monitoring of clinical trials and medical devices in the country.

Regulation
of clinical trials has become important as cases of deaths among
patient groups undergoing drug under trials have become more recently
which sometimes make an outcry form the NGOs and public. According to
official records, 462 deaths of clinical trial subjects were reported
during the year (till June 2010). The number of deaths were 637 in 2009,
288 in 2008 and 132 in 2007.