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WHO-GMP certification mandatory for drug supply under Rajasthan free drug distribution scheme
Shardul Nautiyal, Mumbai | Friday, June 26, 2015, 08:00 Hrs  [IST]

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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