To address the issue of severe shortage of quality plant raw materials in the state, the Gujarat Ayurvedic Aushadh Manufacturers Association (GAAMA) has urged the state government to urgently draft a set of standards for checking percentage of active ingredients in these plant raw materials to ensure quality. The association also wanted the government to appoint a third party company through private public partnership (PPP) for issuing a certification of analysis (CoA), which should be made mandatory, before supplying or procuring plant raw materials.
In this regard, GAAMA wanted the government to enter into a PPP with suitable certification and testing companies to ensure that there is accountability and transparency in the whole process.
These demands come in the wake of absence of any form of guidelines for the standardisation of the raw materials that are used in making ASU drugs. Prabodh Shah, president, GAMMA pointed out that it is high time the government takes some concrete steps towards addressing this issue as the ISM industry is going through a rough phase with respect to accessing standard materials.
“It is a question of existence of our whole industry, as the efficaciousness and effectiveness of the end product depends on the quality of raw materials procured while making these products. Today, we are facing a huge availability crunch of high end raw materials within the country, forcing us to immensely depend on the imported raw materials, the quality of which is again not tested as there is no such mechanism in our country,” Shah said.
At present Indian ASU manufacturers due to lack of cultivation and shortage of plant raw materials procure selected plant raw materials from countries like Afghanistan, Nepal, Iran etc. While some plant raw materials are procured from all across the country, none of these materials is either tested or certified for quality parameters. Shah stressed that considering all these factors there is an urgent need to adopt a two pronged approach, one which will deal with setting up of standards for quality assurance and most importantly appointing a standard setting body or issuing quality certificates of this plant raw materials.
At present there are only two states in the country, namely Kerala through its Care Keralam initiative and Punjab through its Herbal Hill project, test and supply certified plant raw materials throughout the country. GAAMA hopes that the Gujarat government too in the interest of its stakeholders through its Kotler’s incubator for ayurvedic medicines (KIAM) based at Gujarat Technological University will take a proactive step towards regulating this sector for the good of the industry.
In this regard, GAAMA wanted the government to enter into a PPP with suitable certification and testing companies to ensure that there is accountability and transparency in the whole process.
These demands come in the wake of absence of any form of guidelines for the standardisation of the raw materials that are used in making ASU drugs. Prabodh Shah, president, GAMMA pointed out that it is high time the government takes some concrete steps towards addressing this issue as the ISM industry is going through a rough phase with respect to accessing standard materials.
“It is a question of existence of our whole industry, as the efficaciousness and effectiveness of the end product depends on the quality of raw materials procured while making these products. Today, we are facing a huge availability crunch of high end raw materials within the country, forcing us to immensely depend on the imported raw materials, the quality of which is again not tested as there is no such mechanism in our country,” Shah said.
At present Indian ASU manufacturers due to lack of cultivation and shortage of plant raw materials procure selected plant raw materials from countries like Afghanistan, Nepal, Iran etc. While some plant raw materials are procured from all across the country, none of these materials is either tested or certified for quality parameters. Shah stressed that considering all these factors there is an urgent need to adopt a two pronged approach, one which will deal with setting up of standards for quality assurance and most importantly appointing a standard setting body or issuing quality certificates of this plant raw materials.
At present there are only two states in the country, namely Kerala through its Care Keralam initiative and Punjab through its Herbal Hill project, test and supply certified plant raw materials throughout the country. GAAMA hopes that the Gujarat government too in the interest of its stakeholders through its Kotler’s incubator for ayurvedic medicines (KIAM) based at Gujarat Technological University will take a proactive step towards regulating this sector for the good of the industry.
Source:Pharmabiz
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