20 Key Changes for Ayurvedic Manufacturers in Revised Schedule T Draft

The Schedule T guidelines for ayurvedic medicine manufacturers are being revised to improve the way ayurvedic medicines are manufactured. The aim is to ensure high-quality, safe, and effective ayurvedic medicines are being consistently manufactured. In this blog, we have highlighted the key changes introduced in Revised Schedule T. The notification GSR 140 (E) is still in draft and public has till 13th March to put forward their suggestions.

What is Schedule T?

Schedule T provides guidelines for Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani (ASU) drugs. Schedule T falls under the purview of Rule 157 of the Drugs and Cosmetics (D&C) Rules, 1945. Part-I of the Schedule “T” mentions the general requirement for the manufacturing unit for ayurvedic drugs as well as requirements for sterile product. On the other hand, Schedule T’s Part-II mentions the list of recommended machinery, equipment, and minimum manufacturing premises required for manufacturing of various categories of ASU drugs. Additionally, it mentions the list of equipment recommended for in-house quality control. Moreover, supplementary guidelines have been provided for manufacturing mineral/metal-based formulations. Furthermore, it mentions that the factory premises of the plant should have adequate space for receiving and storing raw materials, manufacturing process areas, and quality control section. Additionally, the factory should have provisions for finished goods storage, rejected goods/drugs storage, and an office.

7 key objectives of Schedule T for ayurvedic medicine manufacturers

1. Raw materials are authentic, of prescribed quality, and free from contamination
2. Ensuring the manufacturing process maintains quality control
3. Adequate quality control measures are implemented
4. Ensuring the products are authentic and meet quality benchmarks
5. Ensuring the product quality is consistent with minimal contamination risks
6. Ensuring the finished products meet predefined specifications
7. Ensuring the manufactured ayurvedic drug being released for sale is of acceptable quality

An overview of Schedule T guidelines

The Schedule T provides guidelines for the manufacturing factory premises, raw material and finished goods storage, quality control, water supply, and waste disposal. Moreover, the guidelines cover machinery and equipment as well as production areas. Additionally, it mentions other general building requirements.

• Facility building general guidelines: The building must allow for hygienic production and be free of pests. The interior surfaces of the facility must be cleanable.
• Factory premise requirement: The factory area should be adequately sized and separated for raw material receipt and storage, manufacturing facility, quality control unit, and finished goods storage section.
• Manufacturing area: The manufacturing area should be designed with proper ventilation, exhaust, and chimney.
• Raw materials: Raw materials should be protected from damage that might be caused by dampness, rodent and insect infestation, and microbiological contamination. Additionally, they should be stored in labelled containers indicating source, batch, and receipt date. 
• Machinery and equipment: Manual, semiautomatic, and automatic machinery are usually used. The machinery required will depend on the nature of product and scale of operation.
• Personnel hygiene: Worker hygiene should be given priority. All personnel involved in operations should maintain a consistent level of hygiene. Moreover, the clothing of the personnel should be clean and suitable for the climate and nature of work.
• Dedicated quality control section: A dedicated quality control section of approximately 150 sq ft should be maintained. The quality of raw materials, semi-finished, and finished product should be monitored.
• Documentation: Proper documentation should be maintained, including batch manufacturing records and market compliant records.

We have provided an overview of the Schedule T guidelines. For details and guidance on Schedule T guidelines for ayurvedic manufacturers, feel free to reach out to us.

20 key changes introduced in Revised Schedule T

Schedule T guidelines have been updated. Key changes in Revised Schedule T have been announced on 14^th February, 2025, vide GSR 140(E). All stakeholders may send in their inputs and suggestions regarding this notification by 14^th, March, 2025.  The objections or suggestions sent in within the stipulated date will be taken into consideration by the central government. We have highlighted the major changes introduced in Revised Schedule T:

1. Air curtains will be required at entrances.
2. Steel containers used for storing raw materials should be of at least SS 304 grade.
3. Raw material has to be purchased from GMP certified suppliers only.
4. Process validation, water system validation, and analytical method validation have to be carried out. Also, emphasis has been placed on internal audits.
5. Aluminium partition in ayurvedic drug manufacturing area will not be allowed. Flush partition made of puff panel / brick wall/ gypsum wall will be required.
6. Open pipe fitting, such as water pipe/ air pipe/ electric pipe, will not be permitted. The fittings have to be concealed under the wall or attached directly to the machines. Also, GMP drains have to be fitted to avoid risk of back flow.
7. Ancillary area has to be constructed.  
8. A microbiologist has to be appointed.
9. Open beton/ plastic pipe carrying electric wire will not be permitted.
10. Material receiving and product dispatch bay has to be separately constructed.
11. Only after performing stability studies, the expiry date for the product can be added.
12. Base material composition has to be mentioned on the ayurvedic drug label.
13. Air lock and cross over bench will be required prior to entry to the manufacturing section.
14. Separate man and material flow areas have to be constructed.
15. Equipment qualification, such as DQ, IQ, OQ, and PQ, has to be carried out.
16. The quantity of alcohol present has to be printed in font size 9 or a QR code can be used to present the value.
17. Risk-based inspection will be carried out.
18. Medical inspection of all employees has to be carried out.
19. Samples can be sent to NABL-certified government testing labs.
20. A pharmacovigilance team has to be hired. Also, a quality assurance department will be required to ensure the factory operation is per SOP.

The government aims to revamp the way ayurvedic medicines are manufactured in India and bring the standard at par with allopathic medicines. Hence, major changes have been introduced in the Revised Schedule T guidelines. Ayurvedic manufacturers are expected to be aware of these changes. Furthermore, they are expected to implement these changes and modify their facility according to the Revised Schedule T guidelines. These guidelines are aimed at ensuring ayurvedic drugs of consistent quality and efficacy are being manufactured, thereby safeguard public health. We have provided an overview of the changes mentioned in the Revised Schedule T guidelines. For details and clarification of any queries regarding the applicable changes, feel free to reach out to us.

4 new sections introduced in draft Revised Schedule T

In addition to the existing categories, the following new categories shall be inserted:

1. Saundaryaprasadhak
2. Swarasa
3. AushadhaGhana/extracts
4. Nasal Spray

How can Pharmadocx Consultants help you comply with the changes in Revised Schedule T?

Schedule T guidelines for ayurvedic manufacturers have been modified. Expected changes have been notified in the Revised Schedule T draft published on 14^th February, 2025. Ayurvedic manufacturers will be expected to comply with the new changes in Revised Schedule T after it is implemented. However, as ayurvedic manufacturers it is not possible to stay abreast of the latest guidelines and updates in regulations. This is where the Pharmadocx Consultants team comes in to picture. We have extensive knowledge of the Revised Schedule T guidelines, regulations, and modifications ayurvedic manufacturers will be expected to make. Our team will:

1. Help you modify your manufacturing plant to comply with the changes in Revised Schedule T.
2. Train your staff to equip them with the necessary knowledge of the Schedule T guidelines and the latest changes.
3. Help you prepare all the documents required for demonstrating compliance with Revised Schedule T for ayurvedic manufacturers.
4. Provide holistic support to help you avoid any regulatory sanctions and setbacks.
5. Help ensure compliance with all the clauses of updated Schedule T guidelines. 

Revamping existing manufacturing facilities is a huge hassle and cumbersome process. Fret not! We will revamp your existing ayurvedic manufacturing facility as per changes in Revised Schedule T at minimal expenditure with minimum operation disruption. Our team will transition your facility in a hassle-free manner within the stipulated time so that you do not have to deal with any regulatory headaches. Furthermore, we have now introduced cost-effective teleconsultation services to remotely help our clients.

Thus, complying with the Revised Schedule T guidelines can be challenging. With more than 27 years of industry experience, our team has been helping set up manufacturing facilities per regulatory guidelines since 2007. Call/Whatsapp on 9996859227 or email at [email protected] to make your manufacturing plant Revised Schedule T compliant today in a seamless-manner.