The centre may soon direct the state drug control departments to withdraw manufacturing licences issued by them for several thousands of 'irrational' combination drugs during the last 10 years. The Drug Controller General of India (DCGI) has already sent an order in this regard to all the state drug controllers.
The crucial decision to withdraw license to combination drugs was taken at a meeting of state drug controllers convened recently in Delhi by the DCGI. As per the decision, thousands of licences for the combination drugs sanctioned by state drug controllers will come under the DCGI scanner for review.
Though DCGI is the final authority to give marketing permission for all the new drugs in the country, the state drug controllers are empowered to issue manufacturing licenses for all products of the approved drugs. The former DCGI Aswini Kumar had brought out a directive to the state drug controllers that they should issue license to only drugs listed in the pharmacopoeia. As all combination drugs are considered to be new drugs, prior marketing permission needs to be obtained for them from DCGI. Most of the state drug control departments have been violating this provision for long.
There are more than 1000 combination drugs in the country which are have 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 developing countries. One of the main reasons why the medical fraternity is not prescribing combination drugs is the possible adverse drug reaction of combinations.
According to industry experts, the decision will prove to be a big blow to the industry as the number of combination drugs have grown by leaps and bounds over the years in the country. It is good for the patients as instead of two drugs they have to take only one drug. It is a huge business and it will have a cascading effect as the medium industries are manufacturing these combination drugs for the big players, they said.