Pharmaceutical companies in Tamil Nadu, mostly formulation manufacturers under the small scale industry category, are still trying to come to grip on the issue of complying with the revised GMP (Good Manufacturing Practices) leaving them little time to take note of Research and Development (R&D). The same is not in their agenda as of now. Yet it cannot be completely said that they have ignored the aspect.
Claims an industry source, "Smaller companies have always suffered from cash constraints. They are still figuring out how to go about complying with the revised GMP norms. This means if they have finances they would channelise them into complying with the norms, not R&D."
Few companies have had the courage to go about focusing on R&D. For instance MMC Healthcare, Mano Pharmaceuticals, Apex Laboratories, Chemech Laboratories to name a few. This, leaving aside the two big players, Orchid Chemicals and Pharmaceuticals Ltd and Shasun Drugs and Chemicals Ltd, in the bulk drug sector.
MMC Healthcare, which has presence in the gynaecology, surgery and ortho segment, has launched two new products, one of them being a combination and the other being a line extension. Domz capsules (omiprazole entric coated granules -20 mg) and Domperidone- 10 mg is a combi-therapy for acid related disorder and dyspepsia. With the launch of the combi-therapy product, the company forayed into the gastro-intestinal segment.
The other product launched is Septidase-D, for acute pain and inflammation. The product contains serrapeptidase 15 mg with micrometals, and is a line extension of an existing product, Septidase, that the company currently manufactures and market. The concept of micrometals (cobalt, calcium, zinc and manganese along with diclofenac potassium) was first pioneered by the company in 1993 and helps in increasing the efficacy of the product by over 113 per cent of the original efficacy.
Mano Pharmaceuticals tasted R&D success with one of the products, Methylcobalamin, the second form of Vitamin B 12, launching it for the first time in the country. The product has been introduced both in the softgel and injection forms, and the company plans to introduce the same in liquid form too. The company has also for the first time in the country launched two new products for diabetic neuropathy viz, Biocobal and Diacobal, in strength of 500mcg, in the injectable form.
Chemech Laboratories is now planning to shift its R&D centre from Mumbai to its facility in Gummidipoondi, near Chennai, to be more prepared on the R&D front. It has host of products in the R&D pipeline.
The two bulk drug manufacturers, Orchid and Shasun too have taken the R&D route in increasing not only their mileage but also stamping their class on the R&D front. Orchid which has an exclusive R&D facility at Sholinganallur near Chennai stamped its authority by signing up with US based BEXEL Biotechnology and a joint venture with the North Chinese Pharmaceutical Corporation, China, to set up a joint venture facility in China. Not lagging behind is Shasun which has ongoing tie-ups with Austin Chemicals, and Eastman Chemicals, sharing experience on the R&D front.
All these are but instances of companies realizing that the only way out is focus on R&D and bring out products at a shorter span. "Claims T.K. Sunderaswaran, General Manager, Lancaster Synthesis," Pharma companies have now realized that R&D could bring about a change Finances may be lacking but they have realized that they cannot survive with existing products and need to focus more on R&D. They are now on the look out for companies or organisations which can do R&D on their behalf."
T. S. Jaishankar of Chemech Laboratories is of the opinion that most companies given the chance will look at R&D to survive into the future. "But I don''t think many will come forward because they are tight on the financial front which if eased could result in spurt in R&D.
Not many companies have their own R&D facility or facilities. And this could act as a bottleneck for them to even look at R&D. In to generics for a long time, these companies have not learnt the nuances of R&D though there may be diverse opinions on their capabilities. According to industry sources, if GMP is the bane currently, then R&D could become one once the deadline for GMP expires.
"There is no law stating that a company has to have an in-house R&D facility. The GMP norms addresses the space factor in the R&D facility not the requirement of an R&D facility. While companies will strive to have their own R&D facility it cannot be said that all will have the same. And this could prove harmful to the companies," the industry source averred.
"The R&D expenditure in the overseas is almost 10 to 12 per cent of the overall turnover. But here it is hardly 1 to 3 per cent, and this for the bigger companies, which have taken themselves global. Just think of the small companies," says an analyst with Quest International, a market research organisation. These bigger companies have chartered out the course to be taken with the help of R&D but the smaller companies have not completely chartered out what they are going to do post 2005, the industry analyst avers.
However, another analyst, not wanting to be named, claims that things would change once the GMP complying deadline expires and post 2005 era comes into play. "I am of the opinion that even smaller pharma companies will take to R&D in a big way. Not because they want to do it but because they will be forced to do it. The mainstay will depend on how strong you are in the R&D front in the coming era, and smaller companies will surely make moves to come to terms with R&D.
Finance is one of the major hurdle for these smaller companies. Banks have not been lending without collateral security and this means even if the smaller companies want to set up R&D facility and give thrust to R&D activities they cannot given their financial strengths. Financial institutions have not come forward to help the small-scale sector selecting only a few bigger companies in the segment for funding.
Whatever may be the scene in future, smaller companies have a tough time. On one hand they will have to ensure that they comply with the revised GMP norms, what with the deadline approaching fast, on the other they have to do something drastically to improve their R&D capabilities. The wheel does not stop with a mere realisation that R&D could wriggle them out of the prevailing tight situation. Time only has the answer as to what these companies are going to do.