The newly formed SME Pharma Industries Confederation (SPIC) has made a proposal to resolve the contentious issue of weeding out irrational combination drugs for which the DCGI has called a DCGI-industry meeting at NIPER in Chandigarh on October 27.

The proposals are: 1. Unless data is available for declaring FDCs are irrational, items which have overrun the period of 4 years in the market should be dropped from the list. 2. Items which have run less than 4 years and adverse data is not available, should be referred to a select committee comprising of pharmacologists and industry including SSI. 3. Whenever an item is declared irrational based on adverse pharmacological reports, it should be included in the Banned List and a period of 6 months should be allowed for its withdrawal. 4. The withdrawn items should not be allowed for manufacture as they should go into the Banned List. 5. The New Drug List of FDCs, where no new molecule is involved, should have a period of 2 years for every drug instead of 4 years, which may be taken up for necessary amendment.

SPIC further says that in states like Punjab, before permission for an additional items is granted, SLA asks for a couple of similar drugs available in the market with the application, preferably of large companies. Then new drug list of the DCGI is checked and it is also verified that items in question also do not fall under Banned Drugs as described in Section 26A. Only then permission for additional item is granted with payment of requisite fee. It is a practical method which should stand the scrutiny of law because a better method was not available.

It is also not violative of Rule 122 'E' (c) which says that fixed dose combination of two or more drugs, individually approved earlier which are now proposed to be combined for the first time in a fix ratio, or if the ratio of the ingredients in already marketed combination is proposed to be changed, with certain claims such as indications dosage, forms, etc.

Opposing the DCGI's plea that all new FDCs are new drugs for which permission should be obtained only from DCGI and not the SLA, the SPIC said that this will cost around Rs 1.5 lakh to Rs 2.5 lakh for each item which is out of reach for SSI even if carries a four year period for exclusive marketing rights for the group of companies who make this investment.

The Bioavailability, Bio Equivalence and Toxicity data cannot change from one manufacturer to another when the bulk drug is not produced by the formulator. So there is no rationale of calling it a new drug and asking for same data, especially when excipients are not changed. This was amply demonstrated when it was found that many companies used photocopies of data of other company to get permission from DCGI Office, the SPIC proposal said.