Times of India
22 March 2010
By Alka Shukla

Maharashtra’s FDA allocated over 19,000 kg of the drug in 2008, when the quantity allotted to them was three times less at 6,000 kg; FDA report expected by this month end
Areport released by the International Narcotics Control Board this year has revealed that a whopping 72.2 million Indians are addicted to prescription drugs. It mentions the widespread abuse of pharmaceutical preparations containing narcotic drugs such as ‘codeine’ in India, and its smuggling into neighbouring countries like Bangladesh.

As it turns out, the Maharashtra government may have to answer a lot of questions. For, in 2008, the state’s Food and Drug Administration allocated 19,768 kg of Codeine Phosphate to different companies, when the quantity allotted to them (the state FDA) by the Drugs Controller General of India (DCGI) was three times less at 6,000 kg.

This gross discrepancy was brought to the notice of the Department of Revenue at the Centre by the Chief Controller of Factories.

In fact, K Jose Cyriac, additional secretary, Department of Revenue, wrote on July 30, 2009 to Maharashtra’s Public Health Department, calling it ‘A very serious matter’. The letter said, “…get the matter enquired into and send a report by August 25, 2009, including the systemic reasons, details of the officers responsible, and action, if any, taken against them.” (A copy of the letter is with Mumbai Mirror.)

This was followed by reminders on August 27, September 9 and October 22, 2009. But no action was taken, as it does not control FDA. The correspondence was finally transferred to Department of Medical Education, under which FDA comes, only in November.

Meanwhile, Milind Mhaiskar, who took over as state secretary, Department of Medical Education and Research, late last year, ordered an inquiry this month. “We expect the FDA report by March end,” he said.

Underlining the seriousness of the issue, activist R P Y Rao, president of Society for Awareness of Civil Rights, has written to the prime minister requesting a CBI inquiry. He mentioned that the commissioner of FDA in 2008, Dhanraj Khamatkar (now retired), then drugs controller S A Momin, and the concerned assistant commissioner M G Kekatpure were allegedly behind the allocation. “There is a possibility of the said clique in league with manufacturers for national and international marketers for pecuniary gains…,” he alleged in the letter.

A government source said, “The allocation in 2008 was meant for a few big pharma companies. What are other manufacturers to do? Their businesses get hampered. Who will fix allocation is a continuous fight with the Centre.”

How Drug Allocation is Done
Codeine Phosphate is a Schedule II narcotic drug. Every year the DCGI obtains estimates of requirements for various narcotic drugs from state drug controllers, and sends consolidated estimates to Narcotics Control Bureau.

Once International Narcotics Control Board approves the estimates, the DGCI distributes the quotas to different states.The state drug controllers distribute their quota to pharmaceutical companies.

What is Codeine Phosphate
Codeine is an alkaloid obtained from opium or prepared from morphine bymethylation. It is metabolised to morphine. Medically, codeine based preparations are generally used for cough syrups. It is, however, largely misused as an intoxicant and a hallucinating agent. An overdose can even result in apnea and death.