Several drugs have been allowed to be marketed in the country without mandatory clinical trials, while over a dozen which are banned in most developed markets are being sold in India.
Regulatory dossiers relating to crucial drugs are missing and drugs are being approved based on incomplete data. Firms whose products are to be assessed are influencing the decision making process.
What’s more, currently the country has no full- time Drug Controller General of India and drug regulatory body is severely understaffed.
These are some of the shocking irregularities discovered by the parliamentary standing committee on health which reviewed the status of drug regulation in the country.
The panel scrutinised 39 drugs approved by the Drug Controller General of India ( DCGI) and came up with explosive revelations. In the case of 11 drugs, phase three clinical trials mandated under the law were not conducted.
In the case of two drugs, Dronedarone by Sanofi and Aliskiran by Novartis, clinical trials were conducted in just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients. In case of approval of Irsogladine by Macleods, trials were conducted at just two hospitals as against legal requirement of three- four sites, it says.
Four drugs — Everolimus of Novartis, Buclizine by UCB, Pemetexid by Eli Lilly and fixed dose combination drug of Pregabalin with other agents, were approved without mandatory phase three clinical trials and without any opinion of experts. The decision was solely taken by non- technical staff of the regulatory body.
The ministry could not provide any document on three drugs — pefloxacin, lomefloxacin and sparfloxacin on the grounds that files were nontraceable.
The committee said there were doubts whether the disappearance of the papers was accidental since all three were controversial drugs and approved on different dates and different years. One was never marketed in US, Canada, Britain, Australia and other countries with well developed regulatory systems while the other two were discontinued later on.
“ In India, all the three drugs are currently being sold. It is not possible to monitor if manufacturers are abiding by the conditions of approval,” the report says.
According to information provided by the ministry, 31 new drugs were approved in the period January 2008 to October 2010 without conducting clinical trials on Indian patients.
SC on docs’ strike
In another development, the Supreme Court wants the health ministry to take a decision on banning all such strikes. While disposing of a public interest writ seeking the ban, the court on Monday directed the petitioner to represent to the health ministry. “ If no response is given by the ministry, liberty is given to the petitioner to move the appropriate Court”, the order said.
BEWARE OF THESE MEDICINES
APPROVED WITHOUT PHASE III CLINICAL TRIALS
EVEROLIMUS (NOVARTIS): Breast cancer drug
COLISTIMETHATE (CIPLA): An antibiotic
EXEMESTANE (PHARMACIA): Advanced breast cancer drug
BUCLIZINE (UCB): For appetite stimulation
PEMETREXID (ELI LILLY): A cancer drug
ALISKIREN (NOVARTIS): To treat high blood pressure
PENTOSAN (WEST COAST): Drug for urinary disease
AMBRISENTAN (GLAXOSMITHKLINE): To treat heart disease
ADEMETIONINE (AKUMS): To treat liver disease
PIRFENIDONE (CIPLA): To treat lung disease
COMBINATION OF PREGABALIN, METHYLCOBOLAMINE, ALPHA LIPOIC ACID, PYRIDOXINE AND FOLIC ACID ( THEON): A diabetes drug
BANNED IN DEVELOPED COUNTRIES
Buclizine ( UCB)
Nimesulide injection ( Panacea)
Doxofylline ( Mars)
FDC of Nimesulide with Levocetirizine ( Panacea)
FDC of Pregabalin with other agents ( Theon)
FDC of Tolperisone with Paracetamol ( Themis)
FDC of Etodolac with Paracetamol ( FDC)
FDC of Aceclofenac with Thiocolchicoside ( Ravenbhel)
FDC of Ofloxacin with Ornidazole ( Venus)
FDC of Aceclofenac with Drotaverine ( Themis)
FDC of Glucosamine with Ibuprofen ( Centaur)
FDC of Diclofenac with Serratiopeptidase ( Emcure)
FDC of Gemifloxacin with Ambroxol ( Hetero)
* FDC: fixed dose combination