The Drug Controller General of India's (DCGI) controversial order to withdraw 1105 combination drugs from the drug market seems to have lost in transit. The order has not reached any of the state drug controllers so far. With only verbal order, the state drug controllers are in a dilemma to implement the directive which is giving the drug manufacturers sleepless nights.
Although the decision to act against the 'irrational' combinations was taken more than a month ago, the state drug controllers are yet to receive the same. The decision to withdraw licenses to combination drugs was taken at the consultative committee meeting of state drug controllers convened last month in Delhi by the DCGI.
The DCGI had given a verbal direction to all the state drug controllers in the meeting but that was not followed up with a written order. Interestingly, the DCGI has sent the complete list of 1105 combination drugs to most of the state drug control departments.
According to informed sources, the issue of withdrawal of combination drugs was discussed threadbare in the meeting and it was decided to implement the same at the earliest. The licenses for these combination drugs were issued by the state drug controllers during the last 10 years. Though DCGI is the final authority to give license to all the new drugs, the state drug controllers are vested with powers to issue license to other drugs including combination drugs.
When contacted, a senior officer in one of the state drug controller's office said, "We have completed all the formalities to cancel the licenses issued for the manufacture and sale of combination drugs in the state. We have received the list from the DCGI but we are yet to receive the written order for withdrawing these drugs. The moment we get the order in writing, we will act".
There are more than 5000 combination drugs in the country which are doing well. Combination drugs are usually a blend of two or more drugs which are prescribed by the physicians for multiple disease indications. Most of these drugs are being manufactured by the companies which are existing in the non-exempt states as they have to take license from the exempt states once again for manufacturing these combination drugs.
Though combination drugs are a thriving industry in India, they are not popular amongst practising physicians in developed countries as they are considered to cause adverse reactions on the body.