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...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.
Assistant Director, AYUSH
To assist the Licensing Authority in all the official matters.
4.
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. Sangeeta Nehra, Director-cum-Licensing Authority
Department of AYUSH, Haryana,
Sector-3, (Near Youth Hostel),
Panchkula.
Phone No. 0172-2570919, 2570909
 
Drugs and Cosmetics Act 1940
   
 
Sr. No.
Addresses of the District Ayurvedic Officer-cum-Drugs Inspectors, ASU Drugs.
1.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Ambala.
E.S.I Dispensary, Old Hospital Building, Ambala, Ph. 0171-2556525.
2.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Bhiwani.
25 Bedded Ayurvedic Hospital, Bhiwani, Ph. 01664-241711.
3.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Faridabad.
Civil Sect., 5th Floor, Faridabad, Ph. 2280056
4.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Gurgaon.
817, Sector-4, Near R.T.A. Office, Gurgaon, Ph. 0124-2253649, 09811094376
5.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Hisar
96, Friends colony, Hisar, Ph. 238690 (O), 238331 (R),
6.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Jind.
2571, B. Block, near Moti Lal School, Jind, Ph. 01681-247772
7.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Kaithal.Old tehsil camp, Kaithal, Ph. 01746-233785, 09416147081
8.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Krukshetra. Campus of Govt. Ayurvedic Collage, Kurukshetra,Ph. 223124 (O), 227053, 09416463514
9.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Panipat.
Shanti Bhawan, Railway Road, Panipat, Ph. 0180-2638783
10.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Narnaul
app. Indage tyre factory, Singhana Road, Narnaul, Ph. 01282-252873
11.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Panchkula.
Sector-3, Near Youth Hostel, Panchkula. Ph. 0172-2586160,
12.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Fatehabad.Fatehabad, Ph. 01667-224811.
13.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Rewari.Ravi Dass Hostel, Rewari, Ph. 01274-254367, 09416488119
14.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Rohtak Bharat Colony, Rohtak, Ph. 0162-211314
15.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Sirsa.Old D.F.S.C office, Sirsa, Ph. 01666-242333, 247200 (R), 09416253450
16.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Sonipat.
400-A, New Adharsh Nagar, Sonipat, Ph. 0130-2233861, 2233860
17.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Jhajjar.
Near D.C. Office, Kosli Road, Jhajjar, Ph. 01251-254577, 09416337699
18.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Karnal. Dayanand Colony, Karnal, Ph. 0184-2231212 (O),
19.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Yamuna Nagar.Raghunath puri, Near E.S.I. Hospital, Yamuna Nagar, Ph. 01732-200715, 09416452971
20.
District Ayurvedic Officer-cum-Drugs Inspector, ASU Drugs, Mewat.Mewat, Ph. 09896036538
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:
Time granted
For manufacturing license
Time for grant of licenses, if the conditions are satisfied.
Within 90 days
Time of scrutiny of the application and the documents and communications of shortcomings, if any.
Within 15 days of receipt of application.
Time for inspection of the premises of the applicant firm.
Within 21 days of receipt of complete documents.
Final disposal of application (grant of license of the rejection of the application)
Within 180 days.

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
Rule 153 - Drugs and Cosmetics Act 1945
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:-
i) M/S International Testing Centre (Analytical Laboratory), Plot No. 86, Industrial area, Phase-I, Panchkula (Haryana).
ii) M/S Ozone Ayurvedic, 639-40, M.I.E. Bahadurgarh, Distt.-Jhajjar (Haryana).
 
Rule 160 A - Drugs and Cosmetics Act 1945
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
Rule 157 - Drugs and Cosmetics Act 1945
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:-
 
SCHEME NO. 4
ASSISTANCE TO AYURVEDA, SIDDHA & UNANI (ASU) DRUG MANUFACTURING UNITS TO ESTABLISH AN IN-HOUSE QUALITY CONTROL LABORATORY FOR THE PURPOSE OF QUALITY CONTROL TESTING OF ALL RAW MATERIALS/FINISHED PRODUCTS AS PER PHARMACOPOEIAL PARAMETERS INCLUDING TESTING OF INGREDIENTS/HEAVY METALS/PESTICIDE RESIDUE/MICROBIAL LOAD ETC.
Assistance to ASU&H drug manufacturing units having an annual turnover of upto Rs. 20.00 crores for acquisition of prescribed essential quality control equipment for in-house Quality Control Lab shall be limited to Rs. 30.00 lakhs or 30% of expenditure incurred on the basis of a MoU between the manufacturing unit/State Drug Controller and Department of AYUSH with a condition that the quality control equipment purchased with Government of India will have lien on such equipment in case of company going into liquidation. The acquisition of quality control equipments would be as per Annexure for setting up an in-house quality control laboratory for testing of all ingredients and finished products as per Pharmacopoeial and other standards laid down by Deptt. of AYUSH/WHO from time to time. In the 10th Plan an assistance of upto Rs. 5.00 lakh as back-ended subsidy was allowed to all ASU manufacturing units for becoming Good Manufacturing Practices compliant. However, the off take in the scheme was negligible on account of assistance being very meager. Further, it has been felt that Good Manufacturing Practices notified under Schedule ‘T’ of the Drugs & Cosmetics Act, 1940 and Rules, 1945 does not provide for a mandatory in-house laboratory for every manufacturing unit as a result of which most of the manufacturing units have obtained Good Manufacturing Practices on the basis of having a tie up with an outside laboratory.For all practical purposes testing of all raw material and finished products is not commercially viable unless a manufacturing unit has an in-house laboratory. Development of quality control laboratory is highly capital-intensive. Acquisition of equipments like Atomic Absorption Spectrometer, High Performance Thin layer Chromatography Spectrometer, etc for an in-house quality control laboratory entails heavy expenditure. Small and medium units find it very burdensome to obtain loans without any subsidy. The Parliamentary standing Committee of Ministry of Health & Family Welfare has also recommended substantial increase in assistance to manufacturing units for becoming Good Manufacturing Practices compliant. The grantee institute/State Govt. may apply in the following performa 4 for seeking grant-in-aid under the scheme.
   
 
SCHEME NO. 5
ASSISTANCE TO ASU MANUFACTURING UNITS HAVING A TURNOVER OF UPTO RS. 20.00 CRORES FOR ACQUIRING US FDA/EU GOOD MANUFACTURING PRACTIES CERTIFICATION FOR THEIR UNITS.

Most of the countries are insisting on a higher Good Manufacturing Practices like US FDA/EU Good Manufacturing Practices for granting market authorization to products made by ASU manufacturing units. This may entail substantial expenditure on infrastructure development in addition to establishment/strengthening of in-house testing laboratories. Any applicant manufacturing unit desirous of obtaining assistance under this component shall make an application along with a Project Report duly appraised by a scheduled commercial bank indicating the various items of expenditure to be incurred. The application may be forwarded by the State Directorate of ISM&H or PHARMEXIL. ASU manufacturing units having a turnover of upto Rs. 20.00 crores shall be provided with assistance of 30% or Rs. 30.00 lakh, whichever is less for up gradation of the facilities to US FDA/EU Good Manufacturing Practices certification standards. This would be released through the scheduled commercial bank on receipt of report of disbursement of loan by the Bank and certificate issued by PLIM/ PHARMEXCIL to the effect that the expenditure has been already incurred and US FDA / EU Good Manufacturing Practices certificate has been obtained by the firm.
An Ayurveda, Siddha and Unani (ASU) manufacturing unit shall be entitled to assistance either for in-house quality control component or the higher Good manufacturing Practices up gradation component but not both.
Eligibility Criteria
ASU manufacturing unit should have a valid manufacturing license and a Good Manufacturing Practices and be registered under the Companies Act and in case of Societies like IMCOPS under the Societies Registration Act for least last five years.
Application in the prescribed format would be submitted alongwith trading Profit & Loss Accounts or Sales Tax return showing turnover for the last five years.
Appraisal report of the scheduled commercial bank alonwith certificate regarding sanction of the loan for purchase of equipment for in-house quality control laboratory/infrastructure up gradation for obtaining US FDA/EU Good manufacturing Practices.
In case of up gradation assistance for US FDA/EU Good Manufacturing Practices and independent appraisal by an international consultant regarding the feasibility of the applicant unit obtaining US FDA/EU Good Manufacturing Practices certification after up gradation.
Subsidy of Rs. 30 lakhs or 30% of the expenditure incurred would be released on the basis of certificate issued by Director, Pharmacopoeial Laboratory for Indian Medicine, Ghaziabad and or Director, PHARMEXCIL that the in-house testing laboratory is fully operational and that tall the equipments for which reimbursement is being sought have actually been installed and are being utilized for at least 90 days and that trained manpower is available in the unit or that the unit has obtained US FDA/EU Good Manufacturing Practices certificate. Subsidy will be released through the bank account of the scheduled commercial bank which sanctioned the loan. The grantee institute/State Govt. may apply in the following performa 5 for seeking grant-in-aid under the scheme.
 
 
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Directorate
Ayurveda, Yoga & Naturuopathy, Unani, Siddha & Homoeopathy,
Haryana (AYUSH)
Near Youth Hostel, Sector - 3, Panchkula
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