Laxity and procedural delays on the part of the government to withdraw Rofecoxib urgently from the country is said to be the key reason behind free availability of this drug in the market.
Reacting to the Pharmabiz report on free availability of Rofecoxib brands in different parts of the country despite the announcement of many companies to stop manufacturing and to recall their stocks, sources point out the DCGI is yet to notify the ban.
As per the procedure under Section 26 - A of the Drugs & Cosmetics Act, 1940, the draft notification has to be announced in the Official Gazette and the Drug Technical Advisory Board (DTAB) or the newly formed National Pharmacovigilance Advisory Committee (NPAC)'s recommendation need to be discussed in public for comments. Then the recommendations need vetting of the DGHS, and then only the government can notify the ban, officially. This process normally takes minimum two months to six months. With the government yet to notify the draft ban even after almost two months of the recommendation to ban it, the brands are likely to remain in the market for a few more months, say sources.
They point out, if the government was so keen to implement an immediate ban, the DCGI could have issued an urgent circular to the state drug controllers to ensure Rofecoxib is not sold to the public. They note that Pakistan's Ministry of Health (MoH) immediately ordered pharmaceutical companies in Pakistan to withdraw all their rofecoxib brands, discontinue production and to stop import of the bulk drug, within a few days of Merck's withdrawal of Vioxx. That was how Rofecoxib was withdrawn in many other countries as well. The delay could be a conscious effort to help the companies sell off their stocks, alleged one source.
Sources note the companies had to financially suffer a lot while recalling their stocks, as the stockists and retailers had to be compensated for their losses. That may be one reason for the non-aggressive recall and efforts to dispense the existing stocks, despite decisions to stop further manufacturing. It is only a moral responsibility to withdraw the drug at this context and majority of the companies especially small and medium companies are unlikely to voluntarily withdraw their products.
Various trade sources in South India confirmed that apart from Blue Cross and Unichem, most other companies, including those announced withdrawal of their brands from the market, were yet to officially inform the traders to discontinue sales. Blue Cross is learnt to have issued credit notes worth over Rs 2.5 lakh to stockists and retailers in South India as compensation. In Kerala, most of the popular Rofecoxib brands have been discontinued, according to a trade source. However, some brands are still sold in the retail outlets, though the sales have marginally gone down.