Haryana Medical Services Corporation Ltd.

A- General Provisions

1. INTRODUCTION: Haryana Medical Services Corporation Ltd. (HMSCL) is an undertaking of the Government of Haryana, registered as a company under the Companies Act, 2013. It is the nodal agency for procurement of drugs, consumables for various Government Hospitals, Medical Colleges and other departments, on the request of the Head of the Departments. This policy lays down the procedure and directives to be adopted by HMSCL for procurement by adopting fair and transparent system.

2. METHODS OF PROCUREMENT:- One of the following methods will be adopted by HMSCL for procurement as per the requirement and existing circumstances: -

a) Open tender: The open tender system should be used generally for procurement of goods. Minimum 21 days should be given for bids submission. In case single qualified bid is received in response to an open tender enquiry, the urgency and essentiality of the tendered item will be sought from the indenting department and the case will be put up for consideration of Managing Director, Haryana Medical Services Corporation Limited.

b) Limited tender: Purchase through limited tender may be adopted in the following circumstances: -

i. The competent authority in the indenting department certifies that the demand is urgent, mentioning the nature of urgency.

AND

ii. The sources of supply are known and possibility of fresh source/s beyond those being tapped is remote.

Minimum 10 days should be given for bids submission. In case single qualified bid is received in response to limited tender enquiry, the urgency and essentiality of the tendered item will be sought from the indenting department and the case will be put up for consideration of MD, HMSCL.

c) Short tender: In case of exigencies like pandemic or public health diseases outbreak or any other such emergencies, short tenders giving 3 to 7 days in case of limited tender and 7 to 15 days in case of open tender can also be invited.

d) Procurement of proprietary items through Single Tender:

In case of proprietary items, the Indenting Department shall furnish a Proprietary Article Certificate, indicating the justification. MD, HMSCL shall take final decision to which item be purchased through single tender.

e) Procurement through Government E Marketplace (GeM):

Procurement can also be made through GeM, in which case the terms and conditions of GeM shall be applicable.

f) Alternative procurement: HMSCL can also do procurement from the following agencies: -

i. From agencies/firms and at rates approved by Govt. of India, in case of allocations made by it.

ii. From Public Sector Undertakings at rates fixed by Govt. of India.

iii. From vendors selected by other State Medical Services Corporations, at their approved rates.

g) Procurement under externally funded projects:

For procurement under externally funded projects, the procurement will be done as per the rules/procedures of the funding agency, if mentioned in the terms and conditions of the agency.

3. TECHNICAL AND CERTIFICATION COMMITTEE:-

The Technical Specification of Medicines/Medical Consumables will be framed by a Technical and Certification Committee comprising of following Members:-

For Health Department/National Health Mission, Haryana/AYUSH Department, Haryana.

1) Managing Director, HMSCL- Chairperson

2) DGHS or any Director level representative duly authorized by DGHS- Member.

3) Mission Director or any Director level representative duly authorized by Mission Director- Member.

4) Director General AYUSH or any Director level representative duly authorized by DG AYUSH– Member

5) 1 specialists of the concerned speciality for which Medicines/Medical Consumables is required (to be nominated by DGHS) - Member.

6) 1 representative of the HMSCL (Nominated by MD HMSCL) – Member.

7) In case the Chairperson faces any difficulty in deciding the specifications, Chairperson shall associate a HOD of Government Medical Colleges, PGIMS, AIIMS or his representative of the concerned speciality.

For Medical Colleges/other institutions

1) Managing Director, HMSCL- Chairperson

2) Director/Head of Medical College/Institution/ Other department-Member

3) 1 specialists of the concerned speciality for which Medicines/Medical Consumables is required (to be nominated by Director/Head of Medical College/Institution/Other Department) - Members.

4) 2 representatives of HMSCL. (Nominated by MD HMSCL) – Members

5) In case the chairperson faces any difficulty in deciding the specifications. Chairperson shall associate Director General Health Services, Haryana or his representative of the concerned speciality.

B-Specific Provisions

1. ELIGIBILITY CRITERIA

1.1 INDIAN MANUFACTURERS/IMPORTERS:

Bidder shall be:-

(a) Indian Manufacturer having valid manufacturing licence including a loan licensee OR Direct importer having valid import licence issued by competent authority.

(b) Distributors / Suppliers / Agents are not eligible to participate in the Tenders.

(c) In case of such Pharmaceutical product for which drug regulatory authority issue only repacking licence instead of manufacturing licence, such firm are also eligible to participate in the tender.

(d) Bidders are eligible to quote items only under generic names.

1.2 GMP (GOOD MANUFACTURING PRACTICE)

The manufacturer should have a valid WHO-GMP inspection certificate in line with the WHO certification scheme and Certificate of Pharmaceutical Products (COPP), on pharmaceuticals being quoted, from the appropriate Regulatory Authority (RA). Bidder should submit a valid (at the time of bid submission date) product wise Certificate of WHO-GMP and COPP issued by Regulatory Authority of State/ CDSCO, for each item offered. However, Group C items (please refer to clause No. 1.4) WHO-GM certification tendering authority may consider GMP certificate as per revised schedule M for patient welfare for consumable items for which drug manufacturing licence is not issued ISO/CE certificate is compulsory along with IS certification where ever mentioned in schedule of requirement. For suture items and mesh US-FDA certification is required.

Documents required: WHO-GMP inspection certificate and COPP

1.3 MANUFACTURING AND MARKETING EXPERIENCE

(i) Bidders having minimum three years of manufacturing and marketing experience for a particular item are eligible to quote. A certificate from the concerned State Drug Controller that the firm has been manufacturing and marketing the product/products, for which the firm has quoted the price, for the last three years at the time of submission of offer.

(ii) The condition of minimum 3 years manufacturing & marketing experience however will not apply to drugs, which were introduced in India less than 3 years ago. The manufacturer would be required to submit a certificate from State Licence Authority or Drug Controller General of India in support of their claim.

(iii) For proprietary drugs, if a firm is the sole manufacturer for the products, it can be eligible provided it submits certificate to this effect from the State Drug Controller/ Licensing Authority.

(iv) The bidder should also submit the quantities manufactured and marketed of the items quoted in last three years along with batch size. Documents attested by Chartered Accountant are required.

(v) The merger/amalgamation/transfer of business/transfer of assets etc. of a firm affect the bid condition relating to "past performance" / "Market Standing Certificate" in preceding three years. The eligibility of bidder in this regard shall be ascertained by the purchase committee on the basis of the agreement/BOD/resolution/CA certificate or any other document(s)/certificate(s) which shall be annexed with tender documents provided that the drug is being imported and sold in India for the last preceding three years.

1.4 TURNOVER REQUIREMENTS

Turnover of the Participating firms divided into three Groups as under:-

i) Group-A: Group A covers all Injectables, all doses forms of Antibiotics & Analgesics, Vaccines, Sera, Biologics, Surgical Sutures and Implants. The firms, having a minimum annual turnover of Rs. 30 crores (Thirty crores) in each of the last three years will be eligible for participation.

ii) Group-B: Group B covers Tablet, Capsules, Ointments, Jellies, Gels, Powders, Liquids, Syrups, Suspensions, Solutions of therapeutic groups other than analgesics and antibiotics. The firms, having a minimum annual turnover of Rs.20 crores (Twenty crores) in each of the last three years will be eligible for participation.

iii) Group-C: Group C covers Medical Consumables & Disposables like Bandages, Gauge Cotton, Cotton, Lab, Regents, Dental Material , Proprietary items & other consumables and disposals The firms, having a minimum annual turnover of Rs. 5 crore (Five crore) in each of the last three years will be eligible for participation.

Provided that, if the bidder is importer of a drug, the turnover of the foreign manufacturer will be considered, if the drug has already been registered by Drugs Controller General of India (DCGI) for import into India under Rule 27 —A of the Drug and Cosmetic Rules, 1945, the bid is submitted by a licenced importer and the drug is being imported and sold for the proceeding 3 (three) years in India by the importer and the importer submits documents of CA Certificate, undertaking by the manufacturer and the importer and any other proof in this regard.

Documents required: Audited financial statements for last three years in respect of annual turnover. Group turnover will not be considered for determining the eligibility and CA certified copy of the sale tax return.

1.5 NON CONVICTION/ BLACKLISTING:

a) Firm should submit a non-conviction certificate issued by the State Drug Controller, to the effect that the manufacturer has not been convicted under the Drugs and Cosmetics Act. 1940 and rules there under during the preceding three years for any of the drug for which he has quoted price and that no case /proceeding is pending against the manufacturer in any court of law in India under the Drugs & Cosmetics Act.

b) Bidders are not eligible to submit the bids for the product/products for which the firm /company has been blacklisted/debarred during the period of blacklisting/debarring by:-

(i) Government of Haryana/Corporation

(ii) Any other State/Central Government or Organization due to quality failure of Drugs/Consumables or due to submission of false/fake documents.

c) A bidder shall be debarred from participating if he has been convicted of an offence:-

(i) Under the prevention of Corruption Act, 1988;

(ii) The Indian Penal Code or any other law for the time being in force, for causing any loss of life or property or causing a threat to public health as part of execution of a public procurement contract.

Documents Required: Affidavit by the firm regarding blacklisting debarring and non conviction certificate

2. SHELF LIFE

2.1 The drugs/ consumables should not be older than 1/4th (25%) of its shelf life from the date of manufacture and it should have remaining 3/4th (75%) of its shelf life at the time of delivery. 2.2 In case of vaccines and biologics and imported products the remaining shelf life of 3/5th (60%) or more will be accepted at the time of delivery. 2.3 The bidders should give an undertaking that the firm will replace the unused expired stores with fresh goods. Firm will be informed of near expiry stock 180 days in advance.

3. DELIVERY PERIOD

3.1 Delivery must be completed for entire ordered quantity before the end of 60 days from the date of issue of purchase order at the destinations mentioned in the purchase order, if the above day happened to be a holiday for Haryana, the supply should be completed on the next working day.

3.2 For drug items requiring sterility test, the delivery period will be 75 days from the date of issue of purchase order at the destinations mentioned in the purchase order, if the above day happened to be a holiday for Haryana, the supply should be completed on the next working day.

3.3 Delayed supply: - The supply of goods after the designated delivery period i.e. 60th/75th (as described above) up to 75th/90th days respectively. During this time period, supply will be accepted at HMSCL with liquidated damages described below. No supply will be accepted beyond this period. However the Managing Director of HMSCL may extend the supply period of the firm by 30 days with the stated penalty of 20% on unexecuted supply on request of the firm on case to case basis beyond 75th and 90th day.

3.4 Full Supply: - Any supply more than 90% would be considered as full supply by 75th, 90th 9U days. However payment with respect to actual quantity supplied would be made. No penalty would be levied on the remaining supply till 75th/90th day and no risk purchase will be done.

3.5 Part Supply:-Supply between 60 to 90% ordered quantity of goods by 75th/90th days will be considered as Part Supply and payment of delivered amount of goods will be done after levying liquidities damages on delayed supply and 20% penalty on non supplied quantities on 75th/90th day. Purchase will be done from approved source as per drug policy or Local Market at risk and cost of the firm.

3.6 Non Supply:- Supply of less than 60% of ordered quantity by the 75th/90th days of delivery period will be considered as non supply. Penalty of 20% of unexecuted ordered value along with risk purchase from approved source as per drug policy or local market at risk and cost of the firm. In case of Non supply, the item which has been received would be used by the HMSCL without making any payment to the supplier.

4. PHRMACOPOEL SPECIFICATIONS

IP/BP/USP etc. should be clearly mentioned against each drug/constituent of the formulation quoted as per the provision of Drugs and Cosmetics act, wherever applicable.

5. LABELLING, MARKING AND PACKAGING:

Labelling, marking and packaging conditions will be specified at the time of tendering for individual items

6. BAR CODING:

Firms should adhere to the BSI bar coding system on the outer most packing.

7. QUALITY TESTING

7.1 The supplies should be accompanied with in-house test report. After the receipt of the consignment, the department will draw a sample out of each batch and will send it for testing at one of the Govt. approved testing laboratories empanelled with HMSCL. In case of vaccines, biological, sera, blood products, these are tested by Government Laboratories before release so regular testing is not required if the product is accompanied by test result of a Government Laboratory. However random sampling will be done from to time.

7.2 Along with regular, random testing of drugs will be undertaken from Govt. /Govt. approved laboratories empanelled with HMSCL at the time of supply and at any time during the shelf life or when ever any defect is noticed.

7.3 The firms will be charged 1.5% of the amount of purchase order as testing charges per batch and same will be deductable at the time of payment. In case of firm completing the full supplies within 30 days there will be reduction in testing charges by 0.5%.

7.4 If the sample/samples is/are found Not of Standard Quality the consignment shall he rejected.

7.5 All rejected stores shall in any event remain and will always be at the risk of the firm immediately on such rejection. The rejected stock should be picked up by the firm within 30 days and replacement supplies be made within 60/75 days from the date of intimation to the firm as mention in clause 3.1 and 3.2(Delivery Period). If the firm fails to pick up the rejected stock within 30 days the Department/ HMSCL reserves the right to destroy the stock of its own.

7.6 HMSCL reserves the right for inspection of the pharmaceutical firm participating in the tenders anytime by officers appointed by the Managing Director. They can carry out inspection for assessing the capacity/capability/eligibility of the firm to make supplies and to ensure that good manufacturing practices are being followed by manufacturer. The decision of the Managing Director shall be final in this regard. It is also open to the department/HMSCL to send persons to inspect stores and draw samples before dispatch of the consignment.

7.7 If the vendor fails to lift the expired/NSQ/Bio-medical waste products then the HMSCL shall be empowered to dispose of the same by calling fresh tenders/engaging the vendors approved by the local Civil Surgeon. The expenditure incurred by HMSCL will be deducted from any payment due to the vendor.

7.8 If any item is found to be of NSQ by any Regulatory Authority at a later stage, the entire quantity will be replaced by the vendor free of cost within 60 days irrespective of the fact that part or whole of the supplied goods may have been consumed. In case the vendor fails to replace the same HMSCL shall be empowered to make the recovery of cost of the items from the vendor.

8. LIQUIDATED DAMAGES AND OTHER PENALTIES:

8.1 DELAYED/ NON-SUPPLY:

1. For items not requiring sterility testing, penalty will be charged at the rate of 0.5% per day of the unexecuted order after 60 days till 75th day. After 75th day, the order shall stand cancelled automatically after levying penalty @20% on the value of unexecuted order and such penalty is recoverable from any amount payable to the supplier.

For items requiring sterility testing, penalty will be charged at the rate of 0.5% per day of the unexecuted order after 75 days till 90th day. After 90th day, the order shall stand cancelled automatically after levying penalty @20% on the value of unexecuted order and such penalty is recoverable from any amount payable to the supplier.

For more than two instances of non-supply the RC will be cancelled and firm will be debarred for three years to participate in tendering process for all products.

2. For Purchase orders below Rs. 1 Lakh

1. The conditions of debarring for non --supply should not be applicable for these orders; however the financial penalty clause will remain as such for these cases also.

2. Firms may be given relaxation in logo marking clause, and may be allowed to supply physically hidden MRP with black ink. For All Purchase Orders 1. If the firm completes supply after grant of extension from MD, HMSCL the instance should be counted as Non Supply.

2. For more than three instances of non-supply of a particular item, rate contract of the individual item may be cancelled and not all the items on rate contract. The defaulting firm may he debarred for three years for that individual item.

3. If more than three items of firm are on debarring list due to any reason, then the firm itself should be debarred to participate in the tender for three years for all items

8.2 QUALITY FAILURE

1. If any store/stores supplied against this Rate Contract are found to be Not of Standard Quality (NSQ) on test analysis from Government or Government approved laboratory empanelled with HMSCL and / or on inspection by competent authority, the firm will be liable to replace the entire quantity of failed batch irrespective of fact that part or whole of the supplied stores may have been consumed the department/HMSCL would have all the rights deduct the amount from any of the past or present liability.

2. For more than two instances of quality failure the RC will be cancelled and firm will be debarred for three years to participate in tendering process for that particular item. If more than three products of a firm are debarred/ blacklisted, the firm will not be eligible to participate in the tendering process of Haryana for next three years for any item.

3. Firm may be allowed right to contest the test report from the empanelled lab. In this case the sample may be got tested from Sriram Institute of Industrial Research of similar renowned Laboratories at the cost of the firm.

In case of immunological agents, firms are debarred to participate in the tender for five years, for that particular immunological agent if there is a batch failure/substandard report from any authorized testing laboratory. Five years would be counted from the date of such report.

If the firm fails to replace the batch declared to be Not of Standard Quality, the department/HMSCL will be at liberty to risk purchase from any approved source as per drug policy or local market at risk and cost of the firm.

If the firm fails to replace the batch declared to be Not of Standard Quality on two instances, the firm will be debarred for three years to participate in tendering process for that particular time.

8.3 NON-PERFORMANCE OF CONTRACT PROVISIONS

Non-performance of contract provisions, purchase orders on three occasions will disqualify a firm to participate in the tender for a period of 3 (three) years and its security deposit will be forfeited and no further purchase order will be given to that firm for that item.

9. FALL CLAUSE

If at any time during the execution of the contract the controlled price becomes lower or the contract reduces the sale price or sells or offer to sell such stores as are covered under the contract, to any person organization including the purchaser or any department of Central Government/State Government at a price lower than the price chargeable under the Contract, he shall forthwith notify such reduction or sale or offer of sale to the purchaser and the price payable under the contract for the store supplied after the date of coming into force of such reduction or sale or offer of sale shall stand correspondingly reduced. A undertaking to this effect must be submitted along with tender

10. OTHER RATE CONTRACT CONDITIONS

10.1 The validity of the Rate Contract is two years from the date of finalization of the contract, but in case of exigencies, period can be extended further by mutual consent of both parties up to maximum of 12 months during which new RC would be done and in case the RC is finalized within 12 months extension period, the new RC would over-ride the extended RC which would lapse. Provided that the quantity ordered under the Rate Contract shall not exceed 125% of the quantity mentioned in schedule of requirements. The period of the Rate Contract shall be extended with the approval of Managing Director, HMSCL for a period up to six months and with the approval of ACS Health beyond six months.

10.2 Till the tendering process is not initiated by the HMSCL on its own, the process of risk purchase, debarring, blacklisting along with the penal clause will be handled by HMSCL on its own.

10.3 Furnishing of wrong information and false documents will make the firm ineligible and liable to be debarred/blacklisted from participation.

10.4 In case of any document submitted by the bidder or his authorized representative is found to be forged, false or fabricated, the bid will be rejected and Bid Security Deposit/Performance Security will be forfeited. Bidder/his representative may also be blacklisted/banned/debarred. Report with police station may also be filed against such bidder/his representative.

10.5 Undertaking by the firm that it would own responsibility of any damage arising because delay in supply, non-supply or supply of poor quality of drugs.

10.6 No facility regarding import licence for raw materials etc can be given.

10.7 In all supplies which are branded with the Haryana Govt. supply mark including rejected stocks it would be a condition that such supplies will not be sold to General Public.

10.8 The supply is for seven existing warehouses in Haryana State that is Ambala, Bhiwani, Gurgaon, Kaithal, Karnal, Hisar, Rohtak and two proposed warehouses at Sonepat and Faridabad or any other place in State of Haryana in extra ordinary conditions.

10.9 The HMSCL will not pay separately for transit insurance and the firm will responsible for delivery of items covered by the supply order in good condition.

10.10 EMD will be Rs. 50, 000 for each item up to a maximum of Rs. 2, 00,000.

10.11 Performance Security will be 10% of the estimated purchases to be made in two years however reserve supplier of critical items need not deposit performance security.

10.12 In case of any eventuality where risk purchase has to be done, the Department/HMSCL shall be at liability to procure of drugs from any of the approved resources as per Drug Policy (CPSU, PGIMS, GMCH Sector — 32, PGIMER, ESI RC or any other State of RC) or by open market at the risk and expenses of the firm and the firm shall upon demand paid to the department all such extra charges and expenses as may be incurred or sustained in procuring and testing the same, and same can be deducted against any pending payment/ Performance Bank Guarantee (PBG).

10.13 EXPIRY POLICY: Due diligence should be there at the time of ordering state so that there is no expiry however some lifesaving drugs like adrenaline, anti snake venom, streptokinase etc should be kept at the facilities at all the times even at the cost of expiry. There should be no drug in warehouse whose quantity lying in warehouse is more than 12 month Average Monthly Consumption (AMC). The time lines of quality testing should be strictly followed. For drugs/consumables lying in the warehouse the supplier should be intimated six months before expiry and supplier is bound to replace the said drug after expiry. Also in this regard if the supplier does not replace the drug the cost of said drug will be recovered from the drug will be destroyed by Warehouse Manager after permission from MD, HMSCL as per biomedical waste disposal norms.

10.14 The minimum limit of Rs. 1,00,000 (One lakh) should be there for creation of rate contract. If annual requirement of any medicines is less than one lakh for whole of State HMSCL will not float tender for the same and will not be responsible for providing that medicine in the State.

11. ARBITRATION

In case of any dispute, the same will be referred to the Arbitrator, the ACS/Principal Secretary (Health) to the Government of Haryana whose decision shall be final and binding on both the parties. Subject as aforesaid, the provision of the Arbitration & Conciliation Act, 1966 shall apply to all proceeding of this Act.

12. INDEMNITY

The Managing Director, HMSCL, all employees of HMSCL shall remain at all times fully indemnified and the supplier shall keep every concerned Department duly indemnified against any chemical analysis or statutory inspections/check during the shelf life of the items supplied. It is made clear that no suit, prosecutions or any legal proceedings shall lie against the Managing Director, HMSCL or any other officer/official of the State Govt./Corporation for anything that is done in good faith or intended to be done on pursuance of the tender.

13. AREA OF JURISDICTION

All disputes concerning this tender shall be subject to the civil jurisdiction of Municipal Limits of Panchkula (Haryana) where the registered office of the HMSCL is located.

14. FORCE MAJEURE

The terms and conditions hereof shall not be applicable in case of Force Majeure. Neither Haryana Medical Services Corporation Limited nor the supplier shall be considered in default in the performance of their respective obligations herein above if such performance is prevented or delayed because of act of GOD, natural calamities, War, Flood, Hostilities, Revolution, Civil Commotion, Strike, Epidemic, Accident or Fire, or because of Law & Order Proclamation, Regulation or Ordinance of any Govt. of any subdivision thereof of Local Authority. The bidder shall be entitled to the benefit of this clause only if he informs in writing of the circumstances amounting to Force Majeure to Haryana Medical Services Corporation Limited (HMSCL) for each consignment/dispatch separately within 72 hours of the happening thereof by fax/e-mail immediately, followed by a confirmatory letter sent by Registered Post with acknowledgement due. In the event of approved bidder, pleading any ground as constituting Force Majeure and it does not fall in the specified categories of Force Majeure then the bidder shall not be entitled to plead the same and or claim any relief under this clause.

15. PAYMENT PROCESS

Payment Process will be initiated after the receipt of the goods in the warehouse on the basis of in-house test report provided by the firm along with the supply. Payment will be made within 30 days of test report by empanelled laboratory of Haryana Medical Services Corporation Limited.

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