At a time of ease of business implementation and make in India initiative Joint Drug Controller Dr.V.G.Somani, who is heading FDC division proved himself as an autocratic regulator.
Let’s understand first who is defaulter, drug manufacturing companies or drug controller. Manufacturers have got license from respective state drug controller and manufacturing fixed dose combination since more than 35 years. There is a fight of dominance between state and central drug controller and punishment was given to manufacturers and the poor patients.
If you have cough and cold associated with fever then doctors generally prescribe medicine separately for cough, cold and fever. To make it affordable, easy to prescribe and easy to make available, manufacturer came up with fixed dose combination. Up till now, there is no ADR (adverse drug reaction) report is with the drug controller from all nook and corner of India.
To grab the attention of media one fine day given notice on cdsco website to all pharma manufacturers to submit application for approval, already approved fixed dose combination. In 2013 to 2014 they made restless to the industry and due to that few companies shut down and many are in line to sale. cdsco made millions of rupees from application fee which was illegal, unethical and against the land of the law. Manufacturers were running here and there to prepare application and they submitted application to cdsco rather than concentration on production.
In 2015 cdsco started issuing rejection, show cause notice, data fabrication letter and submission of phase-4 clinical trial report. They banned few companies and consultants for false data fabrication charges. Case filed against dcgi in Chennai and defamation suit filed against dcgi in New Delhi. Industry people came forward on behalf of cdsco to resolve defamation and it had been resolved. Hearing is continuing in Chennai. First time they trid to ban 298 FDC but case is pending in court since more than a decade and this is the second failure attempt to ban FDC apart from 298. Many big issues may be get resolved by meeting and discussing with positive note but when you hurt respect of anybody then they knock the door of judiciary. Now manufacturers and consultants are financially strong and qualified enough to go legally.
Medicare news staff met with cdsco executive on submission counter to know more about phase-4 clinical trial protocol writing but they were not trained enough to reply. If cdsco people are not aware about how to write protocol for phase-4 clinical trial then how come they demand from manufacturers. Protocol protype was not even available on cdsco site that time. Most of the companies submitted PSUR (periodic safety update report) in place of phase-4 clinical trial. Few companies who are financially strong conducted phase-4 clinical tril and invested more than 4 million rupees and even then their product banned.
cdsco is so mismanaged and unplanned in approach that gives a big question mark. They demanded application for FDC but there was no checklist as how to apply. There was no checklist as how to write protocol for phase-4 clinical trial. They banned few companies and few consultants without consultation them. cdsco made fool to the industry. You should conduct workshop for stake holders and consultants so that industry can grow with updated regulation.
Now they banned 350 fixed dose combinations without giving chance to get clarification from the stake holders. Note worthy they have given many approvals without clinical trials. They have doctors in new drug approval committee to decide whether approval should be granted or not.
New drug approval committee should be dissolved immediately because doctors do not know drug and cosmetic act, they are not aware about QA/QC/Product tools to check the quality of medicine. According to golden standard text book of medicine Goodman & Gillman, Martin Dale and Harrison a doctor must diagnose and a pharmacist must prescribe medicine. Hence in drug approval committee doctors has nothing to do as an expert. In this committee QA/QC/Production/Regulatory/Pharmacovigilance/RnD people should be there. The can make worth decision and not the doctors. Why do you appoint B.Pharm for drug inspector post because they know about the drug and why don,t you appoint doctors for the post of drug inspector.
Drug consultation committee has parliamentary power to ban any formulation in consultation with the representative of stake holders and not alone. cdsco has no right to make any decision on the basis of perception and assumption. Medicine is a double edged sword either kills life or saves life. You have included few single drugs in new drug list which are more than 5 years old approved formulation. Who has given power to violate drug and cosmetic act? You cannot cross the boundary of drug and cosmetic act to ease your control.
Globally there is no guideline for formation of fixed dose combination and so in cdsco. You cannot ban any fixed dose combination unless and until you got ADR report from the market. cdsco tried to ban 298 FDC few years back and still they can not ban because case is going on with Madras Court.That time they were not having any ADR report against 298 FDC.
Severe financial impact is there into the market place based on the current MAT valuation for the companies and the subgroups. The major market impact is respiratory with 16.9% of the market coming under this effect followed by pain & analgesics market at 8.2% and antidiabetic at 7.68%
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Most importantly cdsco should take PSUR for all approved formulation on regular basis at least six monthly to cross check the safety pattern of medicine and it should be mandatory whether it is new drug or old drug. Take back banning of 350 FDC and give a chance to stake holder to meet you and let them share their clarification. Noteworthy,stop giving approvals on paper, take sample of finished formulation and API for lab analysis and all approval should be given on the basis of result of lab analysis. For safety of drug, introduce safety tools like PSMF, DSUR, PSUR and end to end case processing of ADR. Industry is not money eyed; they are ready to follow friendly and respectable regulation. You got the 7th pay commission but what about 50 lakh family those will suffer due to your autocratic decision. Industry is ready to follow land of law and on the same time ready to go legally against the autocratic approach if not resolved amicably, industry people informed.