The Central Drugs Standard Control Organization (CDSCO) of India recently issued
initiatives for 2008 through 2012 and the statistics of processed applications
(2005-2009). The initiatives laid out by the Indian medical regulatory body
cover a broad range of issues dealing with drugs, medical devices, clinical
trials and infrastructure.
A sampling of the initiatives is listed as follows:
- The CDSCO will be upping its regulatory manpower by hiring 62 new drug inspectors,
10 new technical officers.
- The CDSCO website will be updated regularly with guidance documents and
a listing of recent approvals.
- All clinical trials must be registered at the central clinical trial registry.
- Schedule M III guidelines for medical devices are now posted on CDSCO website.
- Medical facilities around India must now have a Pharmacovigilance center.
- Commitment to collaborate with international organizations such as the WHO,
the US FDA, the ICH, etc.
- The CDSCO will perform a nationwide survey of fake drugs
- The CDSCO will now issue Certificate of Pharmaceutical Products (CoPP) certificates
under the WHO Certification Scheme.
- Many applications and forms may now be submitted to the regulatory bodies
online, and receive approvals online.
- The bill for the creation of Central Drugs Authority is underway.
These initiatives demonstrate that the CDSCO is prepared to commit to improving
the efficiency and quality of medical devices and drugs distributed to the Indian
public, especially in the midst of a rapidly growing healthcare market. The
market, which is currently sized at $35 billion, is expected to reach $75 billion
by 2012. In addition, there has been a rise in applications to the CDSCO for
everything from new drugs to medical devices. The number of applications rose
from 10,160 in 2005 to 16,945 in 2008.