DCGI to ban few more drugs in india

Its known to major people from this field that there are many drugs baned in other countries like US, Europe, Canada etc for the reason of safety and efficacy issue or harmful side effects but they are still available in our country india. DCGI has started surveying such drugs and already started action to ban all such drugs from indian market. recently the drug Rosiglitazone was banned in india due to safety concerns.
Continuation of that, under the guidance of DCGI, the Drugs Technical Advisory Board (DTAB) has examined few drugs with respect to its safety, efficacy and side effects and concluded that these drugs are to be banned due to its side effects on human beings. These drugs include nimesulide, cisapride, phenylpropanolamine and human placenta extracts. All these drugs will be banned in india very soon after the final decision by DCGI.

Piramal healthcare to withdraw add on I-pill: DCGI

Now days we are watching many advertisement of emergency contraceptive pills and I-pill is one of the pioneer of all. Earlier the DCGI had not taken any action for such ads keeping trust that they will withdraw the ads. After that also piramal healthcare revived the ads again and as a result of that, DCGI has asked strictly to withdraw the add of I-pill.
It is very clear that such advertisement on media will misguide the younger generation and will lead to disease like HI/AIDS and other sexually transmitted disease. DCGI should take very strict action against all such companies who are playing with health of society for the sake of business profits.

Very soon india will also impliment CTD format

The Union ministry of health wants to be in the race with other regulated markets and as a result they have released a draft notification on the preparation of Common Technical Document (CTD) for the activities like import, manufacture and marketing approval of new drugs. The main aim for introducing CTD is to time and resources needed by industry to compile applications for global registration.
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One more drug banned in india by DCGI

Last week i have posted a blog regarding the ban of Rosiglitazone in india. This week, one more drug added to this list which is sibutramine, R-sibutramine and their formulations. DCGI has issued a notice to suspend licenses granted to manufacturers for sales, manufacturing and distribution of sibutramine, R-sibutramine and their formulations with immediate effect. This decision was taken based on study showing very high risk of heart attack associated with this drug. Sibutramine is already banned in US, Europe, Canada and Australia.
(source: Pharmabiz)

Drug marketing approvals may be delinked from patent status

Marketing approvals for generic drugs may soon get delinked from their patent status, a long-standing demand of India’s pharmaceutical industry that depends heavily on the sale of generic drugs.

The health ministry is planning to remove a question on the patent status of a drug from the form that medicine companies fill in when applying to the Drug Controller General of India (DCGI) for regulatory approval, a ministry official said.

The proposal follows a meeting in Mumbai this month between Indian drug makers and health minister Ghulam Nabi Azad.

“Removal of the question of patent status was agreed to, in principle, at the meeting. But now, it has to go to the drug technical advisory board (DTAB, the highest advisory board for drugs) for approval,” the official said, requesting anonymity.

If deleted, the DCGI will issue approvals only on the grounds of drug quality and efficacy.
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Fixed dose combinations will be reduced in india

Since long the battle between pharmaceutical manufacturers and DCGI and FDA is going on for the issue of fixed dose combination of 2 or more drugs. The main issue was these fixed dose combination were marketed without any clinical trials. However the pharma companies were arguing that individual compounds are safe and effective and available in the market since long so the combinations are also safe.

Initially so many irrational combinations was banned by DCGI and now in the line of same, DCGI has issued a guidance for getting marketing approval of the fixed dose combinations. These guidelines apply to manufacture, import and marketing approval of fixed dose combinations as a finished pharmaceutical product considered as new drug as per Rule 122(E) of Drugs and Cosmetics Act & Rules. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) specifies the requirements for approval for marketing of various types of FDCs. The same is further described in the draft to provide a detailed guidance for industry. Finally for such FDCs clinical trials is required to be carried out right from Phase I and in order to get permission for marketing the new drug of such FDCs, along with other required documents.
So now onwards no one can manufacture such fixed dose combinations without any clinical trials data.