A parliamentary panel has indicated a possible nexus between pharma companies, some officials at the Drug Controller General of India and the ?independent medical experts? who have a crucial role in determining whether a drug should be allowed in market.
In what comes across as instance of ?unmatched telepathy?, medical experts and doctors from reputed institutions located at different places across the country have shot off identical letters while recommending the approval of new drugs in the country.
For instance, incase of Clevudine of Pharmasset Inc, three experts from AIIMS, New Delhi; KBN Medical College, Gulbarga and RG Kar Medical College, Kolkata, have submitted word to word identical letters to the drug regulator urging it to allow the company to market the new drug without conducting mandatory clinical trials in the country.
Similarly in case of an anti-psychotic drug ? Sertindole (Serdoclect of Danish company Lundbeck), the panel has found that three experts from Stanley Medical college, Chennai, SKP Psychiatric Nursing Home, Ahmedabad and LTM Medical College, Mumbai wrote letters of recommendation in nearly identical language, with all three using an incorrect full form of DCGI in the address. For Bayer’s drug Rivaroxaban, a drug used to prevent clotting, three opinions from AIIMS, Dayanand Medical College, Ludhiana and St John’s college Bangalore sent to the DCGI’s office are exact replicas of each other.
While the panel has suggested many such examples, what comes across as even more damning instance of collusion is the case of fixed dose combination drug of aceclofenac and drotaverine, in which case, an official at the drug regulator’s office has advised the manufacturer Themis Medicare to not only select experts but also to seek their opinions and deliver then to the office of DCGI. Like all former cases, six medical experts from PGI, Chandigarh; CMC, Vellore; LTM Medical College, Mumbai; Gandhi Medical College, Secunderabad; SCB Medical College Cuttack have recommended the drug in identical language.
The panel has put a huge question mark on who drafts these letters and whether they are being not being drafted by the pharma companies themselves. The panel has asked the ministry of health to direct the DCGI to conduct an enquiry and take an appropriate action against the officials.
The panel has asked the ministry to streamline the process of selection of medical experts who inturm ?must be made? to file a conflict of interest declaration.