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WHO-GMP certification mandatory for drug supply under Rajasthan free drug distribution scheme
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Shardul Nautiyal, Mumbai
June 26 , 2015
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Aimed at ensuring better quality supplies of drugs in the interest of
patient safety, Rajasthan Medical Services Corporation Limited (RMSCL)
has mandated the condition of WHO-GMP certification for all the
manufacturing companies in all the forthcoming tenders floated by RMSCL.
Under
the Rajasthan Free Drug Distribution Scheme, patients visiting the
government hospitals get the essential drugs free of cost and the
procurement of drugs is done through RMSCL, a centralised procurement
agency.
According to a circular from RMSCL, "WHO - GMP
certification issued by the licensing authority will now be a mandatory
condition for bidders participating in the bids published by RMSC from
January 1, 2016 onwards for drugs and medicines. The bidders may
accordingly prepare themselves to meet the said condition."
The
certification is required as improvement in availability and quality of
medicines on sustained basis is of prime concern as this would enhance
acceptance of generic medicines.
If the manufacturers have not
already obtained WHO-GMP certification then they are hereby advised to
secure the proposed certification at the earliest, the circular further
states.
RMSC is the agency entrusted with the procurement and
distribution of drugs and medicines, surgical and suture items to the
government medical institutions in the state of Rajasthan. Main
objectives of the agency are executing procurement of good quality
drugs, surgical and sutures at reasonable prices in Rajasthan to meet
the requirements of government medical and health institutions allowing
healthy competition among pharmaceutical manufacturers, streamlining the
distribution of drugs to institutions and ensuring availability of
drugs at all times, strengthening the system of quality control over
drugs procurement and distribution to make quality an essential
attribute and further promote rational use of drugs.
To achieve
the objectives, procurement policy is being enunciated. As per the Old
Drug Procurement Policy 1988, the pharma public sector undertakings
(PSU’s) registered under the ministry of petrochemicals and fertilizers
were given purchase preference up to 100 per cent, for medicines
manufactured by them. Small scales industries (SSIs) of the purchasing
state were given purchase preference up to 80 per cent, provided they
match the L-1 rates.
The stores purchase organization under
Medical and Health Directorate was doing the rate contract for
medicines, consumables, equipment and instruments. Out of these, the
rate contracts of very few items (approximate 30 per cent) was possible.
The facility of procurement was decentralized and the purchase orders
were given by various department heads and purchase officers
(PMO/CMHO/CHC in-charge etc).
Due to lengthy processes in the
rate contracts, more time, efforts and money was spent. In this system,
there was no provision for annual maintenance contract and comprehensive
maintenance contract for all equipment. The facility of logistics and
distribution was not inbuilt in the system. There was a need for
computerization and improvement in quality control system. There was a
shortfall in the system in assessing the medicine requirement,
consistency in sample verification and Medicine Stores management.
In
order to have efficient management to overcome all these shortcomings,
RMSCL has been established and procurement policy has also been
modified. Under the new policy, procurement of drugs, surgicals and
sutures are to be made by competitive bidding. Purchase preference is
now restricted to 25 per cent only, out of which 10 per cent for state
PSU’s and 15 per cent for state SSI’s, that too on condition that it
would be necessary for them to match with the L-1 rates obtained through
tendering.
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