Continuing delay on the part of the Central and state health ministries in completing the appointment process of a Drugs Controller exclusively for Indian Systems of Medicine (ISM) in Kerala is seriously affecting the prospects of Ayurveda industry in the state.

According to informed sources, procedural delays caused by this indecision are holding up activities of this sector for the last six months. The ASU Drugs Controller (ISM) has been appointed by a central government scheme for the first time in the state. As the process of appointment is not completed he is not in a position to issue licenses including export license or renewal of license and GMP certification. There are around 1200 players in the Ayurveda sector in the state.

Though the appointment order as drugs controller exclusively for ISM in the state has been issued by an order GO(Rt) No.469/06/H&FWD Dated 10-02-2006, the central government has not sanctioned the final order of appointment even after six months of notification. As per the order, the then licensing authority of Ayurveda in the state has taken charge of the post but the licensing powers were yet to be decided.

The post has been created according to a scheme from the central Health and Family Welfare Ministry, for strengthening enforcement mechanism of Ayurveda Siddha and Unani sectors, which also notifies to commence a separate drug control department for the ISM. Kerala is the first state to implement the scheme by appointing an official as the ASU Drugs Controller (ISM) for regulation of ISM sector, informed sources.

The Scheme with a fund allotment of Rs 7.78 lakh and mandate for appointment of one more drug inspector for the new department has been issued by the government in 2004. The central government has to revalidate the proposal again in the current year for issuing the fund, as the money was not utilized in the last financial year. The technical constraints in utilizing fund at appropriate time and the succession process of revalidation is a major reason for the procedural delay, according to the officials. They said that even the remuneration for the licensing authority is also pending for the last six months, as the earlier post has been invalidated and the new post has not been in existence.

The manufacturers are facing serious difficulties without getting their certificates in time from the drugs department and a considerable number of files are pending as the new order is yet to be implemented, according to Dr D Ramanathan, General Secretary, Ayurveda Medicine Manufacturers Organisation of India (AMMOI). The organization has sent appeals to the Ministry of Health and Family Welfare seeking immediate action on the problem. The ayurveda industrial organizations have also formed an action council to take up the issue with due diligence.

"The companies in the state are unable to distribute the products in other states of the country along with enervated export prospects and almost 50 to 60 percent in the total business of around Rs 350 crores, with around Rs 50 crores from exporting, is affected due to the issue", Dr Ramanathan told Pharmabiz.

The implementation of Schedule T in the state, which was already in a slow speed due to the lack of sufficient staff strength has also benumbed due to the lack of a governing authority. The officials informed that the revalidation of the scheme is under consideration of the central government and will be released in the earliest.