A large number of irrational combinations may survive the Drug Controller General of India's latest move to ban combinations drugs, as the decision confines to drugs licensed by the state drug control officials without prior marketing approval from the Central Drug Standards Control Organisation.

The sources said that the Drug Consultative Committee (DCC) which decided to take this action only on those drugs which have not registered with DCGI under Form 46 for "Import or manufacture of new drug for clinical trials or marketing". "The list consists 1015 drugs selected in random basis, from the drugs approved by the state regulatory officials without prior approval of DCGI for marketing and clinical trials," said a member from the DCC.

Meanwhile, a large number of drugs that have slight changes in combination from the regular combination intended to bypass the Drug Price Control Order (DPCO) may persist in the market. "There are more number of combinations, which would come under the definition of irrational combinations, but the matter is how we define this term for action. If we are considering this aspect, there are thousands of drugs on which the action should be taken," a regulatory official told Pharmabiz on condition of anonymity. No comprehensive database of such drugs is available with the regulators at present due to lack of coordination between the drug control departments of various states, added another regulatory expert.

The preparation of database itself is a huge task, as each combination under suspicion has to be examined through various testing processes to arrive at a conclusion. Earlier, while the Maharashtra Food and Drug Administration (FDA) rejected some tinidazole combinations, the Drugs Technical Advisory Board (DTAB) approved that the combinations are rational. This shows the need for thorough scrutiny before approving or rejecting a new combination.

However, the state drugs control officials are waiting for instructions from the DCGI's office with regard to the list. "We have received a copy of the list, but are waiting for official instructions and the copy of minutes of the DCC meeting. Currently, we are identifying the companies on which action should be taken according to the list and will proceed as soon as receiving the specific instructions," according to a higher official from the FDA, Maharashtra.

The instructions from the DCGI may suggest the details of the action to be taken and the definition for the irrational combinations on which the action is based on. "This is the demand of many health workers and NGOs for several years, and is a positive approach. However, we have to study the drugs list issued by the DCGI and to know what criteria has been used to select these drugs. We would welcome the move and give full support to the move, if it is good for public health," commented Ravi Uday Bhaskar, Secretary General, All India Drugs Control Officers Confederation (AIDCOC).

Regulatory experts averred that the negligence from the state drug control departments to abide by the rules and regulations prior to approval of drugs should come under scanner in the backdrop of the action taken by the DCGI.