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CIPI seeks clarification from Bihar DC for ban of formulations of levofloxacin and ofloxacin for paediatric use
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Peethaambaran Kunnathoor, Chennai
September 26 , 2017
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The Confederation of Indian Pharmaceutical Industry (CIPI), the apex
body of small scale drug manufacturers in the country, has sought
clarification from the Bihar state drug regulator for banning sale,
purchase, stock /distribution of the formulations of the drugs,
levofloxacin and ofloxacin, for paediatric uses in the state.
The
manufacturers’ body says that they have examined the list of banned
drugs for the month of September 2017, but it does not contain the
combination product of levofloxacin and ofloxacin. After all, the power
to ban a drug in the country is vested with the central government. No
state government is empowered to prohibit a pharmaceutical product.
According
to Bihar Drugs & Pharmaceutical Manufacturers’ Association (BDPMA),
the state drugs controller and licensing authority, issued a circular
banning the combination of the drugs on September 7, this year, under
Section 85 of the D&C Rules. He issued the ban order without giving
show-cause notices to the manufacturers, or giving time for them to
reply.
CIPI sought elucidation of the action taken by the drugs
controller in the wake of a letter sent to them by the aggrieved
manufacturers from Bihar.
According to Sanjiv Rai, president of BDPMA, formulations of these two drugs (combination) worth more than Rs.60
lakhs are kept in the go-downs of the manufacturers all over Bihar. All
of sudden, without any prior notice, the DC has prohibited the sale of
this medicine. This act of the DC has hit the pharma industry in the
state bringing huge losses to the struggling pharma units.
According to CIPI, a drug product can be banned only under section 26 (A) and the power is vested with the central government.
Opposing
the action of the DC, Sanjiv Rai has sought the intervention of the
state chief minister and the health minister. He said small scale pharma
sector in Bihar is now suffering extremely due to the sudden action of
the drugs control department. According to him, if the drug is banned
for paediatric use, it should be banned all over the country. Banning in
a single state will not fetch the desired result. His association has
also wanted the drugs controller general of India (DCGI) to intervene in
the matter.
Sources from various drug regulatory agencies said
levofloxacin and ofloxacin are part of 344 FDCs banned by the Central
government on 10th March, 2016 citing health risks and lack of
therapeutic justification. Later, the ban was quashed by the Delhi High
Court in the month of December. Following this, the central government
approached the apex court seeking to enforce ban on 344 FDCs. The case
is still pending with the Supreme Court, and till a verdict on this
comes from the court, no state authority can ban the manufacture or sale
of the product, as claimed by the BDPMA.
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