Drug Cell

DRUG CONTROL ADMINISTRATIONS, AYUSH DEPARTMENT, HARYANA

1. Particulars of the organizations, functions and duties:

   Ayu(life)rveda(knowledge), Siddha & Unani systems of medicines being in practice in India of several centuries have a vary scientific background and are accepted at large in India and even at Global level. Keeping in view the demand of ASU Drugs in domestic market as well as in International market, it was necessary to provide guidelines to the business community engaged in manufacturing, processing and trading of these drugs. Besides this it was the State Government duties to implement all necessary provision of Drugs & Cosmetics Act and Rules for ensuring quality control in ASU Drugs. For this purpose the Drug cell has been constituted at Directorate of AYUSH, Haryana, Panchkula. The organizational-cum-hierarchical structure of the Drug Cell is al below:-

   Sr. No.	Official hierarchy	Duties
   1.	Commissioner & Secretary to Govt. of Haryana, Health and AYUSH Department	Appealing Authority
   2.	State Licensing Authority	For providing manu-facturing license and Controlling Authority under Rule 152 of Drugs and Cosmetics rule 1945 for the entire State of Haryana.
   3.	Drugs Inspector ASU Drugs	To carry out inspection of manufacturing units situated within their respective area.

    

2. Appealing Authority :

   A licensee who is aggrieved by the decision of licensing authority for any action taken thereon or whose license has been suspended or cancelled may appeal to the State Government within a period of three months from the date of receipt of the order which shall, after considering the appeal, decide the same.

3. Powers of State Licensing Authority :

   The State Licensing Authority ASU Drugs is the overall controlling authority of all the Drugs Inspectors working in Haryana State. The official functions of licensing authority include:

   1.	Issuing of manufacturing license of bulk drugs and ASU Drugs formulations.
   2.	Assign duties to the officers subordinate to him.
   3.	Pass executive instructions to all the subordinate officers with regards to their duties, area of operations, and other allied functions.
   4.	To accord or refuse sanctions to the Inspectors for initiating a legal actions against a wrong doer person or firm.
   5.	To perform such other administrative functions or issue such executive directions as may be necessary for ensuring the provisions of the Drugs and Cosmetics Act, 1940 and Rules 1945.

4. Powers and duties of Drugs Inspectors :

   1.	To inspect not less than twice a year, all premises licensed for manufacture of Ayurvedic (including Siddha) or Unani drugs within the area allotted to him and to satisfy himself that the conditions of the license and the provisions of the Act and the rules made thereunder are being observed;
   2.	To send forthwith to the controlling authority after each inspection a detail-ed report indicating whether or not the conditions of the license and the provisions of the Act and the rules made thereunder are being observed;
   3.	To take samples of the drugs manufactured on the premises and send them for test or analysis in accordance with these rules;
   4.	To institute prosecutions in respect of violation of the Act and the rules made thereunder.

    

5. General Guidelines with regard to obtaining of licenses for manufacturing of ASU Drugs:

   The Chapter IV-A and Chapter V of Drugs and Cosmetics Act, 1940 is applicable on ASU Drugs. In the same way various provisions mentioned in part XVI, XVI-A, XVII & XVIII of Drugs and Cosmetics Rules 1945 are also mandatory to be fulfilled. The business entrepreneurs engaged in manufacturing of ASU Drugs may see the provisions of various sections and rules of the said Act and Rules made thereunder. For the purpose of details guidelines and clarification of said rules the entrepreneur may contact to the office of licensing authority and District Ayurvedic officers-cum-Drugs Inspectors ASU Drugs. The addresses of Licensing Authority and District Ayurvedic officers-cum-Drugs Inspectors working in Haryana State are given as under for conveniences of General public and proprietors of pharmaceutical units working in Haryana.

   Address of the Licensing Authority ASU, Drugs

   Dr. Satish Khatkar ,Licensing Authority(Addl. Charge), Presently working at Department of AYUSH, Haryana, Sector-3, (Near Youth Hostel),Panchkula. Phone No. 09416070800

   • Drugs and Cosmetics Act 1940(Size: 8.8 MB, Format: PDF, Language: English)

6. Procedures followed in decision making process:

The Licensing authority has set a time frame of the disposal of applications submitted by the applicant for grant of manufacturing license under the Drugs and Cosmetics Act and Rules made thereunder:

7. List of Dossier/Documents required to be submitted along with applications for grant of new license/renewal of license:

An application is to be submitted on form No. 24-D (Specimen is given as under in the link)

• Form 24-D under rule 153(Size: 8.8 MB, Format: PDF, Language: English)
• Rule 153 - Drugs and Cosmetics Act 1945(Size: 8.8 MB, Format: PDF, Language: English)

8. The addresses of laboratories approved under rule 160-A of Drug and Cosmetic Rules, 1945.

The following laboratories are approved under Rule 160-A of Drug and Cosmetic Rules, 1945 for carrying out test for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs or the raw materials used in the manufacture thereof on behalf of licensees. The list of approved laboratory are given as under:-

M/S International Testing Centre (Analytical Laboratory), Plot No. 86, Industrial area, Phase-I, Panchkula (Haryana).

M/S Ozone Ayurvedic, 639-40, M.I.E. Bahadurgarh, Distt.-Jhajjar (Haryana).

• Rule 160 A - Drugs and Cosmetics Act 1945(Size: 8.8 MB, Format: PDF, Language: English)

9. Grant of manufacturing license:

For obtaining new license or renewal of license for manufacturing of ASU Drugs the entrepreneur has to fulfill the all norms prescribed in Schedule ‘T’ with regard to the location and surroundings, buildings, water supplies, disposal of waste, container cleaning, stores for raw material, packing materials, finished goods, working space, sanitations and hygiene of workers, machinery and equipments manufacturing record, distributions record and facility with regard to quality controls etc. Since the compliance of Schedule ‘T’ is mandatory under rule, 157 of Drugs and Cosmetics rules, 1945 for new license and renewal of license so it is necessary to introduce here the provisions of this schedule in details, which are given as under in the link:-

• Schedule T under rule-157(Size: 8.8 MB, Format: PDF, Language: English)
• Rule 157 - Drugs and Cosmetics Act 1945 (Size: 8.8 MB, Format: PDF, Language: English)

10. The Central Assistance Scheme for ASU&H drug manufacturing unit to compete with the GMP standard.

The Govt. of India, Ministry of Health and Family Welfare, Department of AYUSH, New Delhi is providing Central Assistance for ASU drugs manufacturing unit to established an in-house quality control laboratory for the purpose quality testing of all raw material and finished products as per pharmacopoeial parameters including testing of heavy metals, pesticide and microbial load etc. The ASU Drugs manufacturer may contact to the Licensing Authority or District Ayurvedic Officer-cum-Drugs Inspectors for availing the central assistance under the said scheme. For this purpose the Govt. of India has introduce Scheme No. 4 & 5. The details of schemes are given as under:-