India’s Committee on Health and Family Welfare released a 78 page report revealing an 18 month investigation’s findings that support a collusive nexus among pharmaceutical companies, the Central Drugs Standard Control Organisation (CDSCO), and independent medical experts.
The report illuminates the collusive relationship in the stated parties as a means to bypass expensive and time consuming tests to push drugs into the market. During the review of 39 randomly selected drugs, 11 drugs were approved prior to performing the mandatory Phase III trials. Phase III trials serve as a final test of the proposed drugs among different ethnicities living in India. The trials determine if ethnic variances will alter the drug’s metabolism, efficacy, and safety during administration.
Drug manufacturers maintain that the safety trials are not necessary if the drugs were approved in its home country. India’s Health Ministry stated that the head of CDSCO has the authority to approve drugs prior to trial completion in “public interest”.
The Committee also found that files for three drugs under scrutiny mysteriously disappeared and recommendations from independent medical experts were almost identical.
The report recommends that the government re-examines certain drugs that were approved, investigate violations of Indian laws, and prosecute officials involved.
This report has exposed loopholes that emerged in India’s rapidly growing pharmaceutical industry. India is the world’s fourth largest pharmaceutical volume distributor grossing over $12 Billion annually. The industry is growing 10% every year with investors attracted to this emerging market. India boosts 10,500 drug manufacturers and services the outsourced clinical research market.
In light of this report’s findings for this emerging giant in the pharmaceutical industry, it is imperative that drug effectively and safety is not compromised to boost cost savings, high profit margins, and a shortened timeline. India’s primary pharmaceutical market is domestic and its export market makes up roughly 41% of sales. The prematurely approved drugs are distributed world-wide under international labels. The immediate ramifications of bypassing Phase III clinical trials may result in domestic troubles, but the domino effect of unexpected ethnic reactions to the drugs may recourse in unforeseen epidemics.
Finding cost savings by cutting out critical processes for ensuring safety and affectivity leads to short term results with long term repercussions that may eventually cost more in money, time, and human life. Sourcing and process strategies must adhere to ethical standards in order to prove its overall program success.