The Parliamentary Standing Committee on Health and Family Welfare released a scathing report, alleging apparent nexus between the drug companies and drug regulatory officials to approve drugs by brazenly violating mandatory norms.
The firms named by the report include Cipla, Novartis, Bayer, Sun Pharma, GSK, Eli Lilly, Sanofi Aventis, FDC and Macleods. According to the report, the Drug Controller General of India (DCGI) approved one drug on average every month without conducting mandatory trials to check its efficacy and impact on Indian users.
The report said the expert medical opinions were written by 'invisible hands of drug manufacturers and experts merely signed them'.The parliamentary committee looked into the functioning of the Central Drugs Standard Control Organisation, under which the DCGI operates.
As per the report at least 33 drugs have been approved without phase-III trials between Jan-08 to Oct-10. As much as 24 drugs have been approved without expert opinion during this period.
However, several drug manufacturers accused of colluding with the sector regulator and medical experts to allegedly violate approval norms have denied the charges, claiming that the local authority acted independently.
View: Although these companies can not be legally implicated, the report of Parliamentary Standing Committee is set to to caution the drug regulators, which may come out with stricter policy for new drug approvals.
It may be noted that Indian Pharma market has been growing in lower double digit over past few years, which is partially contributed by new drug introductions. A stricter new drug appproval policy may delay new drug introductions in the market, which may impact the growth.
....more info
The firms named by the report include Cipla, Novartis, Bayer, Sun Pharma, GSK, Eli Lilly, Sanofi Aventis, FDC and Macleods. According to the report, the Drug Controller General of India (DCGI) approved one drug on average every month without conducting mandatory trials to check its efficacy and impact on Indian users.
The report said the expert medical opinions were written by 'invisible hands of drug manufacturers and experts merely signed them'.The parliamentary committee looked into the functioning of the Central Drugs Standard Control Organisation, under which the DCGI operates.
As per the report at least 33 drugs have been approved without phase-III trials between Jan-08 to Oct-10. As much as 24 drugs have been approved without expert opinion during this period.
However, several drug manufacturers accused of colluding with the sector regulator and medical experts to allegedly violate approval norms have denied the charges, claiming that the local authority acted independently.
View: Although these companies can not be legally implicated, the report of Parliamentary Standing Committee is set to to caution the drug regulators, which may come out with stricter policy for new drug approvals.
It may be noted that Indian Pharma market has been growing in lower double digit over past few years, which is partially contributed by new drug introductions. A stricter new drug appproval policy may delay new drug introductions in the market, which may impact the growth.
....more info