E-DRUG: Indian parliamentary probe damns drug regulation
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The following editorial has appeared in the Monthly Index of Medical Specialities (MIMS), New Delhi, India in its May 31, 2012 issue:
Probe unearths unholy nexus between doctors, drug producers & drug regulator
After more than a year-long scrutiny of the functioning of the Drugs
Controller General (India) [DCGI] and closely examining over 10,000
documents spanning over 10 years, the multi-party 31-member Parliamentary
Committee on Health and Family Welfare has found to its dismay
that:
• files on three (pefloxacin, lomefloxacin and sparfloxacin) out of 42
currently sold drugs selected randomly have mysteriously disappeared.
In all DCGI approved 2,167 drugs in the past decade. Thus the Parliamentary
scrutiny was limited to just 2 per cent. All the missing files
pertain to controversial drugs either not approved or discontinued in the
West.
• at least one new drug is being approved every month without trials on
patients in India in violation of rules, sparing the pharmaceutical manufacturers the cost but putting the life and limbs of people at risk. Drugs cleared without adequate mandatory trials include Everolimus and
Aliskiren of Novartis, Exemestane of Pharmacia, Ambrisentan of
GlaxoSmithKline and Dronedarone of Sanofi.
• even in those cases when trials were conducted the very purpose was
defeated because all ethnic groups living in India such as Indo-Aryans,
Dravidians, Mongoloids etc. were not enrolled. It is well known that the
metabolism of many drugs such as rosuvastatin differs in different racial
groups.
• since there is no medically qualified person on the staff of DCGI,
generally the opinion of outside experts is sought on safety and efficacy
of new drugs before approval or before granting permission to
conduct trials in India. Strangely, in 64% cases, such opinion was not
obtained.
• even when opinion was obtained, in most cases these chosen experts
were based in Delhi. In the case of five drugs, in all 25 experts
were consulted but 23 of them were from Delhi. Apparently DCGI believes
elhi is India and India is Delhi.”
• globally discarded and potentially dangerous drugs such as analgin
are allowed to be sold in the country. Analgin was banned in 1977 in the
United States and subsequently in most part of the world including
Sweden, France, Canada, Japan, Australia and even in developing countries
like Nepal, Vietnam, Syria, Yemen etc. Yet it has not been banned
in India.
• drugs not approved in the country of origin such as Buclizine (Longifene) from Belgium and Deanxit (FDC of flupenthixol and melitracen) from Denmark have been cleared for sale in India in flagrant violation of
Indian laws.
• as many as 33% drugs approved for use in India do not have permission
for sale in any of the major developed countries (United States,
Canada, Britain, European Union nations and Australia). None of these
drugs have any special or specific relevance to the medical needs
of India. These drugs include Nimesulide injection, Doxofylline,
FDC of Nimesulide with Levocetirizine, FDC of Pregabalin with
other agents, FDC of Tolperisone with Paracetamol, FDC of Etodolac
with Paracetamol, FDC of Aceclofenac with Thiocolchicoside, FDC of
Ofloxacin with Ornidazole, FDC of Aceclofenac with Drotaverine, FDC
of Glucosamine with Ibuprofen, FDC of Diclofenac with
Serratiopeptidase and FDC of Gemifloxacin with Ambroxol.
• noted and eminent experts from premier medical institutions such as
Dr. Randeep Guleria, Professor of Pulmonary Medicine and Dr. Rajesh
Malhotra, Professor of Orthopaedics at All India Institute of Medical
Sciences, New Delhi; Dr. Dheeraj Gupta, Additional Professor of Pulmonary
Medicine and Dr. Promila Pandhi, Professor and HOD of Pharmacology
at Postgraduate Institute of Medical Education and Research,
Chandigarh; Dr. M. Thirunavukarasu, Professor and HOD of Psychiatry
at Stanley Medical College, Chennai; Dr. Kalpana Ernest, Professor
and HOD of Clinical Pharmacology at Christian Medical College, Vellore
have been obliging drug manufacturers by signing “ghost” (i.e. company)
written optifying the safety and efficacy of drugs both from MNCs and domestic manufacturers. In all 30 such experts have been named in the Report. The Committee recommended that in future all opinions of all experts on all drugs should be uploaded on the website of DCGI for public and peer scrutiny. Such a procedure will encourage experts to give honest opinion instead of signing ghost-written letters drafted by drug manufacturers.
• in the case of Fixed-Dose Combination of aceclofenac with drotaverine,
not permitted in any developed country, the DCGI obliged the applicant
Mumbai-based Themis Medicare Ltd. not only to select experts, but
approach them for their opinions and then submit the same to his office.
• while DCGI has been blaming state level drug controllers for issuing
licenses to irrational Fixed-Dose Combinations of two or more drugs,
he himself has approved at least 11 such drugs, Naturally he can hardly
take action against state controllers even though he has powers to do so.
• no action has been taken against pharmaceutical manufacturers who
are promoting drugs for unapproved indications such as Deanxit by Lundbeck.
• officials of DCGI have colluded with drug companies in labeling New
Drugs as old drugs thus sparing scrutiny required by law, but putting
patients at grave risk. Example: Placenta extract gel. In this case the
application from Albert David Ltd, Kolkata dated 7th February 2000 not
only reached the office of DCGI but approval given in a record time of
just four days.
The Committee came to the conclusion that most of the ills and malpractices
of drug regulation in India are on account of DCGI functioning as promoter and facilitator of drug industry though his statutory duty is to protect public health. This mindset must change and change soon enough; otherwise heads must roll.
Dr. P. Talwar, MD
Consultant Physician
rptalwar@yahoo.co.uk