``Worse, we'd have to go to the plants at Mohali or Tonsa three to four times before the process would stabalise,'' says Naresh Kumar, associate vice-president, chemical research, Ranbaxy Research Laboratories. He smiles: ``Now we go there maybe, once in two years?''

The boffins are beaming. For, suddenly, vitaminising Ranbaxy's R&D division is a unique quality practise called Design of Experiments (DOE). Across the globe, it's an R&D technique used primarily for automobile and automotive component design. But, for the first time in thehistory of Indian pharmaceutical research, Ranbaxy has put DOE on the front burner in chemical research for bulk drug manufacturing.

In the last few months, the impact on Ranbaxy has been Viagra-esque:

* The lab to commercialisation time has been slashed by a whopping 25 to 30 per cent.

* In one instance the cost of raw material used in a bulk drug shrunk by 30 per cent. In another product, material costs fell by 10 per cent.

* Re-work at the scale-up stage had reduced dramatically.

* The processes developed are more robust, and the failure rate is plummeting.

What exactly is Design of Experiment? Essentially, it's a statistical tool for systematic experimentation, whose application extends right from brewing a perfect cup of tea, and improving a car's steering system, to developing a new least-cost drug formulation. According to RS Chalapathi, whose start-up Quality Improvement Consultants has not only helped implement DOE at Ranbaxy but also at SamCor Glass Ltd: ``It's a scientific way toanalyse the causes which affect a phenomenon.''

It also brings fun back into the laboratory. For, without DOE, there are just two ways an experiment can proceed. The first is hit-and-miss: you take all the possible ingredients for making tea, choose what you think are the best combinations of sugar and milk and tea leaves, and as soon as you get the first potable cup of tea, you stop experimenting. But, this way, you never know whether you have made the most tasty cup of tea or not.

The second method is cover-all-bases. If you are mixing ten fragrant oils with two quantity levels each in the quest of a fragrance, then to test all permutations and combinations, you will have to undertake 1024 experiments. And only then--regardless of the high time and cost involved--will you finally get the best possible perfume.

Now, imagine having the confidence to cover the results of all 1024 experiments through just eight specially designed experiments--and the power of DOE begins to shine through. It certainlydawned on Ranbaxy, which realised in early 1997 that if it wanted to achieve world-class standards it would need a breakthrough concept in the very manner in which it conducted research.

Explains Naresh Kumar: ``The key to success for us in the generics business, is entry to market. But if we tried to cut short the cycle-time from the lab to the commercial scale, there was a risk in terms of quality standards. To deal with the risk as well as cut short experiments we felt the need for DOE.''

While the DOE revolution quietly started at Ranbaxy 18 months ago, it's pay-back time now: yields are up (in one product, by 17 per cent), and costs are down (in one formulation, the quantity of zinc chloride used has been sliced by 38 per cent). Adds Arun Kumar Malik, director, continuous improvement, culture change and quality management (CCQM): ``Our confidence about the control of processes is also much more. We now know exactly which parameter to play with.'' Best of all, cycle times are shrinking. If in thepast, Ranbaxy took two to three years to develop a bulk drug from the lab stage to the manufacturing stage, through DOE it has now reduced the process to just eighteen months, on average. At Ranbaxy, which is constantly racing against time, DOE has already passed the critical litmus test of speed.

(To be concluded)