A section of drug manufacturers in the country are contemplating to move contempt of court proceedings against some of the state licensing authorities (SLAs) for refusing to renew licenses to combination drugs 'in violation of the Madras High court stay' on former DCGI's order for withdrawing 294 irrational FDC drugs from the market.
The manufacturers are annoyed over the attitude of the SLAs in some states that even though a successful discussion for a long lasting solution to the protracted FDC issue is going on between the DCGI and the industry, the SLAs continue to refuse to renew licenses to these products. "Even though a consensus on as many as 138 combination drugs has already been reached in the DCGI-industry meeting way back on July 14 last year, the SLAs continue to delete these drugs from the renewal list. They direct us to go to DCGI office in Delhi for renewal of licenses. Now, we are exploring all possibilities including moving of contempt of court proceedings against them," an industry source said.
Industry sources said that they have consulted legal experts, including the government legal advisors, on the issue. Legal experts are of the opinion that since the Madras High Court has stayed the order of DCGI, its jurisdiction will be all over the country. "Pleased to grant an order of stay of all further proceedings of the impugned order of the Respondent dated 14 August, 2007 in F No 19013A/2007-D so as to enable the petitioner's members to produce and market FDC drugs (in MP 1/07) pending WP . No 35844 of 2007 respectively," the Madras High Court stay order reads.
But, even after the Madras High Court stay order, SLAs in most of the states refuse to renew licenses to combination drugs on the plea that in the absence of any formal letter from the new DCGI Dr Surinder Singh, they are still following former DCGI Dr Venkateshwarlu's directive of October, 2007 in which the former DCGI had asked the SLAs to cancel the licenses of 294 irrational FDC drugs.
Though the DCGI had issued minutes of the July 14 meeting to the SLAs in which a consensus decision on 138 combination drugs was taken, the DCGI is unlikely to issue a fresh directive to the SLAs on the issue before a final solution is found on all the 294 controversial drugs. The manufacturers' ire stems from the fact that they do not see a final solution to issue in the near future given the pace in which things are moving in the DCGI office on the issue. Even after more than three months of its constitution, the expert panel on FDC is yet to have its first meeting. The panel will take up the remaining 156 drugs for review in phases.
Meanwhile, the slow progress in officially finalising a solution to the FDC issue is providing an uneven playing field to the drug manufacturers in the country, benefiting a section of companies. While the drug companies which have received licenses relatively recently continue to manufacture these contentious drugs after the Madras High Court stay, others whose licenses have expired are not getting the licenses renewed from the state drug authorities.