Assuring quality medicines

The hour-long discussion at the Healthcare Senate presented by Glenmark Pharmaceuticals focused on how hospitals should assure quality medicines to the comman man.

The discussion began with Dr Suresh Saravdekar, Director, The Rural Centre, Krishnamurti Foundation of India and Ex-Assistant Director and Consultant (hospital supplies procurement), Ministry of Medical Education & Health, State of Maharashtra, pointing out that   maintaining quality of medicines is a continuous process. He went on to say how important it is to shift from assumed quality to assured quality of drug.

Sharing his views about quality medicine, Dr Milind Khadke, General Manager, clinical administration, Kokilaben Dhirubhai Ambani Hospital, said, “We need to focus on research molecule. A stringent clinical trial policy is needed, though India has a policy in place  and the current scenario is better than what it was around 10 years ago, much needs to be done. We also need to concentrate on logistics and cold chain.”

“In order to assure quality of the medicines, we need to develop and establish some standards and timely evaluation of the same,” said Yogendra Nath Awadhiya, Head – Hospital Operations and Administration at Wockhardt Hospitals.

Jaiprakash S Vastrad, Sr General Manager, Sagar Pharma, Bangalore said, “In India, the pharma market  should concentrate more on the quality concept of the drug products. We need to educate manufacturers  as well as conduct studies on areas such as certificate analysis and chemical equivalence .”

Further,  AG Prasad, Vice President- Sales and Marketing, Glenmark said, “During the post independence era multinational pharma companies dominated the Indian market. The Government of India wanted to encourage the local players and had liberalised formulations so much that they are finding it  difficult to contend it now. Moreover, there are 13,000 manufacturers but only 29 testing laboratories. And there was a time when WHO Good Manufacturing Practice(GMP) was required only for the drugs which were exported; but today we have 500 companies that are accredited with WHO GMP and upgraded to Certificate of Pharmaceutical Product (COPP).”

While Prasad’s suggestion was commended by the participants, Ajay Vij, Head – Supply Chain Management, Fortis Healthcare Limited, Gurgaon, informed that quality comes with a cost. He stressed that manufacturers should follow all the quality standards and maintain the consistency in what they manufacture.

“Manufacturers have to go that extra mile to ensure that the whole supply chain is well maintained. When it comes to quality assurance of drugs, we lack the consistency at three levels — manufacturing, supply chain and in the hospitals. This is crucial and should be taken care of,” Vij added.

While Prasad concluded the discussion by thanking all the participants for sharing their views on this extremely important subject, the dignitaries unanimously agreed that investment in quality manufacturing, and in depth analytical test report and good practices would assure quality medicines. The dignitaries opined that the industry and the service providers should come together and maintain a registry or data of the  therapeutic results of the two different companies of the same drug and analyse it. A concrete data can help in quality medicines.

Summing up the discussion, Prasad said, “Even countries like Nepal and Bhutan are more stringent with regulations. The standards and guidelines set by the government of India should also be more stringent.”