Drug Controller General of India has scheduled a series of formal meetings with the State drug controllers to impress them on the need for acting on weeding out of irrational combinations from the market. DCGI had already issued a direction in this regard some time ago.

"We are determined to move ahead further in this matter. I have talked to the State Drug Controllers already. Now I am going to meet them formally. The first formal meeting of State controllers from the South will be held on September 17. I hope to finish the meetings within a month,'' DCGI Dr M Venkateswrlu told Pharmabiz.

On the response by the States to his earlier direction to ban the irrational combinations, he said his office was monitoring the steps by the States and some of them had initiated steps in this regard.

Talking about the irrational combinations in the market, he said "we don't call them irrational as their efficacy and side effects are still to be assessed.'' However on the number of 294 drugs listed by his office, he explained that those were not cleared by Delhi so far and thus were to be withdrawn from the market."

After the DCGI wrote to the States directing them to take action to stamp out the listed irrational combinations, States like Karnataka have acted by asking the companies to withdraw them. However, many of the States were yet to take any steps in this regard. This has prompted the DCGI to meet the State drug controllers formally to follow up his direction.

It is also viewed that reviewing the huge number of combination drugs available in the market is a tough task as there is no comprehensive data on the number of such combinations. There was no serious effort yet on the part of the authorities to ascertain the number of combination drugs.

So far only 79 fixed dose combinations have been banned in the country, specially after these were banned elsewhere and the data was made available to the authorities. Most of the combination drugs are tonics, vitamins and antacids. There are at least 140 combinations of oneprazole and 120 brands of cefadroxil, according to industry observers. Hence, finding out the number of combinations was almost impossible.

It is also pointed out that the companies who rely on combination drugs as their `bread and butter' will try to surpass the order of the DCGI by changing the combinations and retaining the same brands in the event of the authorities acting tough.

Lack of data was one of the main hurdles in taking action against the irrational combinations. The recent move was initiated based on the studies of NPPA, Indian Drug Review, MIMS and CIIMS. The authorities, expressing their inability in this regard was asking the public interest groups and experts to come out with data on the efficacy of the combinations so that they could be listed as irrational.

According to industry sources, an estimated Rs 3,000 crore of pharma business will be immediately affected due to the DCGI order. Apart from the end product, the decision to withdraw irrational drugs will also have a chain affect on the raw materials, packaging industry, promotional materials, etc.