The appointment of former Super Cop Julius Rebeiro and former Delhi Police Commissioner Vijay Karan into the Expert Committee formed under the chairmanship of Dr R A Mashelkar, Director General, Council for Industrial and Scientific Research (CSIR), which is constituted by Government of India to look into seven major and allied issues related to Drug Regulatory System in the country, has stirred up a debate among the small drug manufacturers.
The Committee was constituted chiefly to find means to control the spurious drug manufacturing in the country, apart from suggesting changes in the required Acts to tighten the noose around culprits.
Apart from representatives of different Union Ministries, the Union government had appointed nominees from different organizations including the Indian Pharmaceutical Alliance (IPA), All India Small Scale Drug Manufacturers Association and Organisation of Pharmaceutical Producers of India (OPPI).
Julius Rebeiro's reputation of an ardent functionary of the IPA preceded him in the appointment. This appointment has become an eyesore for several small drug manufacturers who feel that they are `ill-represented' in the Committee. Further, they have termed Vijay Karan as a `non-technical man' to solve the purpose of the committee.
The Madhya Pradesh Small Scale Drug Manufacturers Association (MPSDMA) has become the first organization of the small-scale sector to officially register its objection to Sushma Swaraj, Union Health Minister, Ashwini Kumar, Drug Controller General of India, and Dr Mashelkar, among others.
In a letter to the dignitaries, Jagmohan Rai Agrawal, Chairman, MPSDMA, has stated that the representation to Indian Pharmaceutical Alliance (IPA) and Julius Rebeiro, who is engaged by the IPA, is repetition as it's members are already being represented by either Organisation of Pharmaceutical Producers of India (OPPI) or Indian Drug Manufacturers' Association (IDMA).
At the same time, only one representation from SSI sector deserves review and at least four Zonal Associations may be considered for representation in the Committee. This seems to be more logical and convincing in view of wide presence of representatives from organised sector, he stated.
Commenting on Vijay Karan's appointment, the MPSDMA Chief said, ``Vijay Karan, Ex Commissioner, Delhi Police, has probably no role to play as the matter involved is of Techno-legal nature.''
Notably, a large hue and cry was raised by the industry over the manufacture of spurious drugs, which has dented the coffers of the genuine manufacturers to a great extent. With the `ill-representation' of the SSI sector (as felt by small manufacturers), most of them believe that the axe might fall on them, even if they stick to the quality standards.
The MPSDMA has warned that improper and ineffective representation from pharma SSI in the Committee would cause serious prejudice to the small sector as it is the SSI, which deals the Drug Regulatory at ground level. The prevailing provisions of law to regulate import, manufacture and sale of drugs in the country are more than enough and considerably stringent.
"What is lacking is honest, sincere and devotion towards its uniform implementation, which this Association is confident, can be achieved under the present set up only," told the MPSDMA to the Health Minister.
The Government of India, may be unknowingly, playing in the hands of MNCs and large scale and crushing to untimely death of pharma SSI in the country without any valid reason, the letter said adding, proper and rational representation to pharma SSI in 'committees' constituted by either Government of India or states is denied for reasons best known to the Ministry or its officials.