Mumbai: The Bombay High Court today asked
Maharashtra FDA, Drug Controller of India and Narcotic
Commissioner of India to file a reply in four-week on a PIL
alleging that the state Food and Drug Administration is
allocating excess amounts of Codeine Phosphate, an opium
derived ingredient of cough syrup, to pharma companies.
Codeine, which is used in almost all top cough syrup
brands, is a habit-forming substance, and only government
companies manufacture and supply it to pharma companies.
According to Society For Awareness of Civil Rights,
the petitioner organisation, since it is an opium product,
International Narcotic Control Board controls its global
Every country is is allocated a quota, depending on its
medical needs. India too is member of INCB.
The PIL said after INCB decides how much codeine India
can manufacture, Drug Controller General (India) allocates a
quota to every state. FDA authorities in the state in turn
decide how much codeine the local pharma companies can
But, the PIL alleged, the state FDA is violating the
quota system. Citing an example, it said in 2008 Drug
Controller General allocated 6,000 kg of Codeine Phosphate for
state, but Joint Commissioner and Drug Controller, FDA,
distributed 23,944 kg of Codeine to pharmaceutical companies
in the state.
Besides, as per the Narcotics Drugs and Psychotropic
Substances Act, a person or a company can consume only 200 kg
of Codeine in a year, for medicinal purpose.
This cap is being grossly violated as many major pharma
companies are getting as much as 1,000 kg of codeine, the
petitioner`s lawyer C J Sawant said.