The recent news reports of document forgeries in drug manufacturing and quality certifications of facilities are quite embarrassing to the office of the Drug Controller General of India. Such reports do damage the very credibility of this august office amongst the pharmaceutical industry and the general public. The report about the detection of a large number of forged new drug approval letters by the Food and Drug Control Administration of Gujarat last month was certainly shocking. The Gujarat FDCA, although issued manufacturing licenses based on these fake letters, later found about the forgery and withdrew the licenses issued by it. The Gujarat police also arrested one of the main suspects and the matter is currently under investigation. It is just possible that some of the other state drug authorities might have also issued manufacturing licenses based on these fake new drug approval letters. But no one knows how many such licenses were issued by the other state drug authorities and whether they have been withdrawn. The Union health ministry has, however, appointed a 'work team' to go into the whole issue of such forgeries and asked it to submit a report at the earliest.
The functioning of the office of the Central Drugs Standard Control Organization has been under attack for some time and Pharmabiz reported a complaint of the pharmaceutical companies about the chronic delays in clearing various regulatory approvals by the CDCSO in its July 22 issue. Some of the representatives of pharmaceutical companies have described the performance of CDSCO as dismal and blamed it for not having a systematic approach to processing and disposing off various approvals. These representatives or agents have never been so bitter about the functioning of CDCSO. The health ministry should have taken note of this simmering anger and despair of the drug units. The emergence of the racket of forged drug approvals is only a fall out of this unsatisfactory working of this key Central government office. Inadequacy of qualified staff and poor infrastructure could be one of the reasons for the inordinate delays in clearing approvals considering the steady spurt in the number of applications reaching the office of the DCGI in recent years. But that is no excuse for a serious system failure like availability of fake drug approval letters. Transparency in the office of DCGI in matters like clearance of a new molecule or a new drug combination could, probably, be of some help. An industry suggestion in this regard, that any new drug or FDC approval by the DCGI, should be posted in CDSCO website immediately, makes some sense. The state drug authorities cannot, then, commit an error in issuing a wrong manufacturing license. This is a practice followed by world's top drug regulatory agencies like US FDA and UK MHRA.