Licences & Manufacturing

Every product we sell is a licensed Ayurvedic medicine made at a GMP-certified unit in Wayanad, Kerala. This page publishes the licence numbers so you can check them rather than take our word for it.

Our own drug licence

Two of our products — Thrupthan Migraine Oil and Samhara Skin Solution — are Thathasthu formulations approved under our own licence.

Detail
Licence number 11/25E/2024
Type Loan Licence, Form 25-E under Rule 154-A
Licensee Thathasthu Herbals, Ambalavayal, Wayanad 673593
Issued by Deputy Drugs Controller (Ayurveda) & Licensing Authority, Kerala
Date of issue 3 June 2024
Approved drugs Thrupthan Oil — KL 11/25E/2024-AYU.(P)/001
Samhara — KL 11/25E/2024-AYU.(P)/002

What a loan licence actually is

A loan licence under Rule 154-A of the Drugs and Cosmetics Rules lets a company manufacture its own approved formulations on someone else's licensed premises, instead of building and certifying a factory of its own.

The licence, the formulation and the product approval are ours. The premises, the equipment and the expert technical staff are Aswini Ayurvedic Pharmacy's. Each product carries its own approved product code, and manufacture happens under the supervision named on the licence.

It is a normal, fully regulated arrangement, and it is the reason a small Wayanad company can put out a properly licensed Ayurvedic medicine rather than an unregulated "herbal" product with no licence at all.

The manufacturing unit

Both our own formulations and the Aswini range we stock are made at the same premises.

Detail
Unit Aswini Ayurvedic Pharmacy
Address Door No. SB 13/1A, Chethalayam P.O., Sulthan Bathery, Wayanad District, Kerala 673592
Manufacturing licence 10/25D/2018, dated 25 July 2018
GMP certificate No. 976, Form 26 E-I under Rule 155-B
GMP standard Schedule T, Drugs and Cosmetics Rules 1945
Valid to 24 July 2028
Issued by Drugs Control Administration, Government of Kerala

Approved dosage forms

The unit's GMP certification covers six dosage forms. That range is why a single unit can produce an oil, a churna and a rasayanam to the same standard:

  • Arishtasavam — fermented preparations
  • Thailam / Kuzhambu — medicated oils. Our Thrupthan, and the Vasabringamalakadi, Karmukhil and Orthokare oils
  • Kashayam — decoctions
  • Lehyam — semi-solid preparations. Sidhikalpam Rasayanam
  • Choornam — powders. Diacare powder
  • Gulika — tablets and pills

Who supervises manufacture

Our licence names the expert technical staff responsible for production and quality control at the premises:

Name Qualification Registration Responsibility
Dr. K.S. Surendra Mohan DAM Reg. No. 3771 Manufacturing
Dr. Rakhi Mohan BAMS Reg. No. 9523 Quality control
Amjatha M.A BSc Chemistry — Quality control

What GMP under Schedule T means

Schedule T sets out the requirements for Good Manufacturing Practice in Ayurvedic, Siddha and Unani manufacture: the premises and their layout, equipment, water quality, raw-material identification and testing, batch records, and qualified technical staff on site.

A GMP certificate is issued after inspection by the state drugs authority and runs for five years. It is not a badge a company can award itself, which is exactly why it is worth looking for. A great many Ayurvedic products sold online come from units holding no such certification, and nothing on the listing would tell you.

Who makes what

Product Whose formulation Under which licence
Samhara Skin Solution Thathasthu 11/25E/2024 (ours)
Thrupthan Migraine Oil Thathasthu 11/25E/2024 (ours)
Vasabringamalakadi Hair Oil Aswini 10/25D/2018
Karmukhil Hair Oil Aswini 10/25D/2018
Orthokare Oil Aswini 10/25D/2018
Diacare Powder / Capsules Aswini 10/25D/2018
Sidhikalpam Rasayanam Aswini 10/25D/2018

Verifying any of this

Both licences were issued by the Drugs Control Administration, Government of Kerala. The numbers above are printed on the product packs. If you are a practitioner, pharmacy or distributor and need copies of the certificates for your records, email info@thathasthu.in and we will send them.