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We should feel proud that we have immense number of FDC approval from CDSCO. Now
we should take process patent on priority. Pharmaceutical companies should innovate more
and more FDC. CDSCO generally give priority in approval for FDC those approved
anywhere in US or Europe. CDSCO should remove block barrier that even any FDC if not
approved in US or Europe can be approved first time in the world by CDSCO. Tapentadol &
paracetamol combination has been rejected whereas Tramadol & paracetamol is approved
with CDSCO. It is noteworthy tramdol is 100% opiod where as tapendaol is 50% opiod and
50% non-opiod. Tapentadol is safer than tramadol. Hence tapentadol & paracetamol is better
alternative and it should be approved in India.
There was a myth that India is a global hub of irrational fixed dose combination and mostly
without cdsco approval fixed dose combination. In September, 2012 cdsco had stopped
further approval of FDC from state drug licensing authority and those FDC approved after
1988 after the introduction of Rule-22E were advised to apply for approval from cdsco.
Those applied for approval from cdsco are entitled to continue manufacturing and marketing
till the final decision. Those who had not applied for approval from cdsco are not allowed to
continue manufacturing and marketing. cdsco given directive to state drug licensing authority
to stop renewing manufacturing license to those who had not applied for approval from
cdsco. cdsco also given directive to state drug licensing authority not to issue any new license
to manufacture FDC.
In the mid of July, 2015 cdsco started giving approval/ rejection/show cause notice/phase-4
clinical trial to those who applied FDC. cdsco has taken a remarkable decision to provide safe
and quality medicine. PSUR (Periodic Safety Update Report) has to be submitted six monthly
in first year and then annually till forth year from the date of approval. cdsco made
mandatory for phase-4 clinical trial or PMS (Post Marketing Surveillance) for few FDC
application to safeguard the quality of medicine.
An analysis of fixed-dose combination (FDC) products can provide insight into evolving
therapeutic needs and point the way to new product opportunities. Now India has only
rational combination and cdsco is controlling quality of medicine by strong
pharmacovigilance system in place.
Of the 131 FDC products approved by the US FDA since 1990, it was previously noted that
the majority of these products comprise pharmaceutical actives that had been previously
approved. This is not surprising as the approval process for a new chemical entity (NCE) is
sufficiently challenging that combining two or more unapproved actives substantially
increases the associated risks and the costs. It is perhaps better to gain approval as a single
entity NCE, properly understand its characteristics in a large population, and then pursue
additional combination opportunities.
Of the 131 approved FDC products, a total of 87 (66%) were developed by, or in active
partnership with, Big Pharma companies. Among the leading companies were Merck with 10,
Novartis with 9, and GlaxoSmithKline with 8 FDC products. A list of companies is provided
in Table 1. Specialty Pharma companies accounted for an additional 42 FDC products. The
leading companies in this regard were Gilead with 4 and Valeant with 3. The remaining
Specialty Pharma companies for the most part developed 1 or at most 2 combination
products. Emerging biopharmaceutical companies, those without any product revenues,
accounted for the remaining 2 approved FDC products.
Its not surprising that the majority of the 131 FDA-approved FDC products have been approved in
multiple markets around the world. What is surprising is that fully 41 of the total number of 131
products have only been approved in the US, or Canada. Of the 131 FDA-approved FDC products, a
total of 19 (15%) have managed to capture more than a billion dollars in annual sales.