Expert committee for licensing/approval for ASU drugs

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Expert committee for licensing/approval for ASU drugs
10-Oct-19 14:48:30

The Ministry of Ayush has issued an order (F.No.T. 13011/4/2019-DCC (Ayush) dated 12.2.2019 to the State Licensing Authorities to constitute expert committee for licensing/approval for ASU drugs. The order has been done in exercise of the power vested under Section 33P of the D&C Act, 1940 with a purpose of facilitating the licensing or approval of ASU drugs in a coherent fashion. The fresh order is in supersession of the Central Government Order NO. K.11027/02/2007 DCC (Ayush), dated 04.01.2008.  

Section 33P – the power to give directions
The Central government may give such directions to any State government as may appear to the Central government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made there under.

Composition of expert committee 
A.    Senior most ASU officer in the office of State Licensing Authority or Director (Ayush),
B.    Expert of Dravyaguna/IImul Advia/Gunapadam,
C.    Expert of ASU Pharmacy or Rasa Shastra/Saidala/Maruntgu-Alunur,
D.    ASU Drug Inspector.

When it comes to the qualifications of the expert committee, obviously a postgraduate qualification in Dravyaguna/IImul Advia/Gunapadam and ASU Pharmacy or Rasa Shastra/Saidala/Maruntgu-Alunur shall be the answer. Further, a fair selection process must be exercised for selection of the experts of the subjects mentioned above. The members of the expert committee must have exposure to national and international Ayush affairs. Some State Licensing Authorities have employed professionals having GAMS or BAMS qualifications. This must be rectified by infusing experts with MD qualifications having sound knowledge about Ayush regulatory affairs. 

Several companies have ventured into new field of phytopharmaceuticals and majority of the experts already working in the team of state licensing authorities have brief knowledge about this. It is expected that expert of ASU Pharmacy having sound knowledge of herbal extracts or botanicals can solve the applications dealing with phytopharmaceuticals. Alternatively, a person having background in phytochemistry can be drafted in the expert committee. 

Ayush drug control cell
The Drug Control Cell has been made Ayush-Vertical of the CDSCO since February, 2018 to deal with the provisions of Drugs and Cosmetics Act, 1940 and Rules, 1945 there under and the associated matter pertaining to ASU&H drugs. In this regard, the Cell coordinates with the State Licensing Authorities and Drug Controllers to achieve uniform administration of the Act and for providing regulatory guidance and clarifications. 

The Ayurveda, Siddha and Unani Technical Advisory Board (ASUTAB) constituted by Government of India is responsible for the enforcement of the provisions of the Drug & Cosmetics Act, 1940 applicable to ASU drugs. The Ayurveda, Siddha and Unani Drug Consultative Committee (ASUDCC) advise the Central and State governments/Board on matters for securing uniformity in the country in the administration of the Drugs and Cosmetics Act. ASUTAB and ASUDCC have definite goals to achieve and expect to play a stellar role in development of Ayush regulatory affairs.  

Licensed pharmacies under Ayush
To meet the increasing demand of Ayush medicines, and to provide Ayush medicines of reasonably good quality, there is a need to have licensed pharmacies for Ayush medicines with good manufacturing practices. In 2017, there were 9038 Ayush drug manufacturing units (licensed pharmacies) in the   country. Out of these, 99.5 per cent of the licensed pharmacies were controlled by non-government bodies, and only 0.5 per cent licensed pharmacies were in government sector. A trend of 0.09 per cent per annum has been observed in the number of licensed pharmacies under Ayush systems during the period 1994-2017. During 2016-17, the annual growth rate of Ayush pharmacy industry has increased by 4.3 per cent. However, status of licensed pharmacies under Ayush is awaited for 2017-18 session. 

Revamping is required 
The fresh order issued by the Ministry of Ayush is a much desired step. The present situation for Ayush drug licensing/approval is not in a sound state. The manufacturers put blame on the state licensing authorities for delaying in issuing or reissuing the drug manufacturing license. Creation of Ayush drug control cell and expert committee for licensing/approval for ASU drugs are a welcome step so as to expedite the process of proper services from the state license authorities. 

The need of the hour is proper orientation between the department of Ayush, state license authorities and Ayush drug manufacturers. Several big players of the conventional pharmaceutical companies are willing to diversify into Ayush drug manufacturing including herbal/Ayush cosmetics. With phytopharmaceuticals catching up Ayush/herbal drug industry rapidly and CDSCO issuing Certificate of Pharmaceutical Product (CoPP), the writing is on the wall itself. With paradigm shift from Ayush model of manufacturing to FSSAI or phytopharmaceuticals, the initiative taken by the department of Ayush in constituting an expert committee for licensing/approval of ASU drugs is a welcome step for survival issues of Ayush pharmaceuticals and drugs. 

Dravyguna expert in the committee
Dravyaguna is an important subject of Ayurvedic curriculum at graduate as well as postgraduate levels of the study. Dravyaguna is sometimes referred as Materia Medica or Pharmacognosy. Dravyaguna has a significant impact on Ayurvedic regulatory affairs. The experts of the Expert Committee for Licensing/Approval for ASU drugs must have practical exposure to norms of the Drug and Cosmetic Act applicable to ASU drugs and rules and regulations for the international market. Herbal formulations based on crude drugs, standardized extracts and phytopharmaceuticals have direct link with Dravyaguna regulatory affairs. 

Rasa Shastra expert in the committee
Rasa Shastra like Dravyaguna has direct linkage with Ayurvedic regulatory affairs. This subject is often referred to as latrochemistry (old terminology) or Indian alchemy (new terminology). The scope of Rasa Shastra has been limited after heavy metals issue raised and published in Journal of American Medical Association. The irreversible damage done to the overseas market of bhasma (ash) is apparent from reduced sales. The syllabus dealing with MD Rasa Shastra course has been designed by keeping in mind the changing trends. The expert joining the Expert Committee for Licensing/Approval for ASU drugs should have sound knowledge about Rasa Shastra regulatory affairs so that genuine/no-toxic formulations submitted by the ASU drug manufacturer is not missed out. 

Impact of expert committee on Ayush carrier prospects
Ayurvedic pharmacy (Ayurvedic or Ayush Pharmaceutical Sciences) has always a limited value as far as lucrative career is concerned. Decisions like constitution of the expert committee for licensing/approval for ASU Drugs taken by Ministry of Ayush is expected to boost career for persons holding MD or M. Pharm qualifications in Dravyaguna and Rasa Shastra. The Ministry of Ayush and State Drug Licensing Authorities must ensure selection of professional sound professionals so that a cordial relationship is established between manufacturer and government organizations. 

Ayush regulatory affairs have remained in hibernation until propaganda done by Ministry of Ayush in last five years or so. The State Drug Licensing Authorities more in relax mood in implementing provisions of the Drug and Cosmetic Act applicable to ASU formulations. The ASU drug manufacturers were least bothered in obeying the provisions of the Drug and Cosmetic Act applicable to ASU formulations. Ayush regulatory affairs need a new direction and by issuing an order for expert committee for licensing/approval for ASU Drugs a step towards streamlining the whole process has been taken.