Notwithstanding the successive stay orders from the Madras High Court on the FDC issue, the pharmaceutical companies in the country are leaving nothing to chance for uninterrupted marketing of their products as they are rushing for clinical trials of their products, both the fixed dose combination (FDC) drugs and the single ingredient products.
The pharma companies apprehend that the court's stay order is a temporary reprieve and once the stay gets vacated, they will be left with no other option but to approach the DCGI office for license to market their products. The DCGI is already on record saying that his office will go to any extent to ensure that irrational drugs are withdrawn from the market. In such a scenario, only the clinical research data will come to the rescue of the pharma companies.
According to sources, thousands of pharma companies are thronging the clinical research firms for getting the clinical trial reports of their products as early as possible. The companies want bio-availability (BA), bio-equivalence (BE) and simple stability study of their products to submit to the DCGI office in Delhi for getting new licenses from the DCGI.
Though several of these products have been in the market for years, the DCGI has recently insisted that the pharma companies should get new licenses from the DCGI office for marketing their products. The DCGI has sent a directive to the state drug controllers to take action against the 294 FDC drug manufacturers in the country. For getting license from the DCGI, the companies have to submit new data (BA/BE or simple stability data, depending on the product) to the DCGI office.
Sources said that though the Madras High Court stay order has given the much needed reprieve, the pharma companies do not want to take chances for the uninterrupted marketing of their products. They are trying hard to get the clinical trial data of their products ready for submitting the same to the DCGI office by the time the court vacates the stay.
Meanwhile, the clinical research firms seem to be the biggest beneficiary of the DCGI action on FDC. Apart from the FDC drugs, the companies are approaching the clinical research firms for clinical data of the single ingredient products as they do not want to take any chances now in the wake of the on-going controversy over the FDC drugs for which, the DCGI says, were given licences by the state drug authorities without proper clinical study.
Sources said that the clinical research organisations in the country are utilising their facilities to the hilt as orders are come knocking. "I have added two new machines to my facility in a month's time with an investment of Rs 2 crore. I am running my units in three shifts", a clinical research organisation MD said on condition of anonymity. A single machine can make a billing of at least Rs 5 crore in a year.
While it takes between 3 to 6 months for the BA/BE and stability study as per the international standards, it takes only one month for the study as per the Indian standards. For a BA/BE study it takes around Rs 6 lakh, the stability study costs around Rs 50,000, the MD said.