The Drug Controller General of India (DCGI) is learnt to be under tremendous pressure from the pharmaceutical companies on withdrawal of irrational combination drugs from the market as it affects a large number of drug units. Even after two months of his directive to the state drug controllers to withdraw licenses of irrational combinations, the DCGI is yet to send the order in writing.
The decision to withdraw licenses to more than a thousand irrational combination drugs was taken at a meeting of state drug controllers convened by the DCGI on June 4 in Delhi. As per the decision, thousands of licences for the combination drugs sanctioned by state drug controllers during the last over one decade were to come under the DCGI scanner for review. And instead of sending the order and the list of drugs together, he just sent only the list of irrational combination drugs to be withdrawn.
The state drug controllers in different states have made all preparations to withdraw manufacturing licenses of the drugs listed by the DCGI. "We have completed all formalities for implementing the DCGI order but did not receive any order or the minutes of the meeting in writing so far. We cannot act without DCGI's written order. The moment it comes, it will be implemented in letter and spirit", a senior drug control department official from a state said adding, "He might be under pressure from the drug companies".
Though DCGI is the final authority to issue manufacturing licenses for all the new drugs, the state drug controllers are also empowered to issue licenses for combination of approved drugs. Often misusing this power, state drug controllers during the last more than ten years have issued manufacturing and marketing licenses to thousands of combination drugs, at times even without much of a stability study.
According to a conservative study, there are around one lakh combination drugs in the country which have a huge market. Combination drugs are the mix of two or more drugs which is prescribed by the doctors for a combination of diseases. 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 widely prescribed in India, they are not usually prescribed by the physicians in developed countries like US, UK, etc. One of the main reasons why the medical fraternity is not prescribing combination drugs is the possible unknown adverse drug reaction of combinations.