Hello. This is my first post here (found this forum today). Am looking for some help regarding manufacturing of Pharma and Ayurvedic products. Namely, are they allowed to be produced in the same premises (Under the same roof)? Or should the facilities be completely segregated. Thus far I have gone through Indian and WHO GMP guidelines and not come across anywhere specifying separate facilities for the two.
Any help will be deeply appreciated.
Please refer to Schedule T of GOOD MANUFACTURING PRACTICES FOR AYURVEDIC, SIDDHA, AND UNANI MEDICINES specified in the Drug Rules 1045 of the Indian Drugs and Cosmetics Act 1940. Also, please refer to Rule 157 of the Act under the Rules 1945.
Hello. Mr Budhkar and Kavya, thanks a lot for your responses. I have gone through Schedule T especially Rule 157 as referred by Mr Budhkar. However, I could not exactly refer from them that Ayurvedic and Pharmaceutical products need to be completely segregated. It is not clearly stated, as for example, in case of external and internal preparations it is clearly stated in unambiguous language.
Hello Sir,
I agree with your views that the manufacturing of (allopathic) pharmaceutical products can be undertaken in common premises of Ayurvedic products. However, my interpretation about the same is given below.
Please refer to the clause in Part-II of schedule-T of GMP requirements of Ayurvedic products.
PART II
A. LIST OF RECOMMENDED MACHINERY, EQUIPMENT, AND MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS CATEGORIES OF AYURVEDIC, SIDDHA SYSTEM OF MEDICINES. It states in the table of list of equipment that,
One machine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Similarly, some of the manufacturing areas like powdering, furnace, packing of liquids and Avaleha, Paks, could also be shared for these items. Similarly, it is stated that 1200 square feet covered area with separate cabins partitions for each activity. If Unani medicines are manufactured in the same premises an additional area of 400 sq. feet will be required.
Therefore, it is permitted to manufacture Unani products in the same premises.
However, it does not state about the manufacturing of (allopathic) pharmaceutical products.
Moreoever, if common premises, areas and equipment are used for both the type of products (Allopathic pharmaceuticals and Ayurvedic product), it will be difficult to determine absence of ayurvedic products in the allopathic products during cleaning validation studies. This is because the composition of Ayurvedic products is very complex and it contains several ingredients which can not be qualitatively and qualitatively determined as required to ascertain their absence in the carry-over residues of Ayurvedic products in to Allopathic pharma product. This is when common equipment is washed after manufacturing of Ayurvedic product and changed to manufacture allopathic pharma product.
Besides, there will be several other GMP-related issues if both type of products are manufactured in the same premise and equipment, specifically manufacturing highly potent Ayurvedic products like bhamas and churnas as they may content heavy. poisonous metals like Arsenic, Mercury, Copper, Gold compounds.
Hence, I suggest that there should be separate buildings to manufacture Ayurvedic and allopathic pharma products, but may be in the same premises with adequate separation and dedicated air handling systems, utilities and working staff.
Hello. I understand that is your opinion. But unfortunately I was mainly looking for clear guidelines saying Ayurvedic and Allopathic medicines need separate premises.
Also I never really stated that allopathic and ayurvedic can be manufactured in the same premises so that was misreading of my comment on your part.
Like I said in my first post I have gone through every single guidelines in details when it comes to Indian GMP but have not clearly come across this point. That it can be infered in the case of ayuvedic products with heavy metals is fairly obvious. But there are a lot of ayurvedic products minus heavy metals which have clear cut markers to determine their qualitative and quantitative aspects, same as herbal medicines. So theoretically their manufacture in the same premises should not create any problem GMP wise. WHOGMP in fact allows production of herbal medicines with pharmaceutical medicines in the same premises.
Anyways what I can definitely conclude from this discussion is that nobody in this forum is aware of any clear written guidelines stating the requirement of separate premises for Pharma and Ayurvedic. That could be either because such guidelines dont exist or nobody here has come across it. That will be all. Thank you very much.
Yes please. I agree with you that no such clear-cut guidelines I came across.
You may have to contact CDSCO (Indian FDA) officials and request a meeting in person to seek their opinion on this matter.
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