The drug manufacturers should go beyond the job of producing medicines and put in place their own monitoring systems to ensure that no duplicate medicine resembling theirs is entering the market, Dr M L Ranga, health minister Haryana, said here. Exhorting the industry to keep vigil against spurious drug manufacturers, he wanted the licensed drug makers to join hands with the law enforcement agencies to put an end to this practice, thereby redeem the image of the industry.
Addressing hundreds of small and medium scale drug manufacturers at the inaugural function of a workshop on Schedule M organized by Indian Drugs Manufacturers Association (IDMA) North Zone here on October 15, 2004, the minister wanted Haryana to be the first spurious drug free state of the country. He assured the delegates of making all essential drugs tax free once the Central government comes out with a uniform list of emergency / life saving drugs.
The workshop was the fourth one of its kind organized by the SSI Sub-committee of IDMA for the benefit of small drug makers in the country. Delegates from states like Uttar Pradesh, Haryana, Rajasthan, Uttaranchal, Punjab etc attended the one-day workshop.
Speaking on the occasion, Dr Sujan Chakraborty, MP & chairman, LOC, 56th Indian Pharmaceutical Congress Kolkatta, strongly condemned the practice of relating SSI drugs sector with the manufacture of sub-standard and spurious drugs. "Its never the case that SSIs are bad. They are quality conscious and they are more socially responsible than the big pharma when it comes to the supply of low cost, quality drugs to the general public. The Schedule M requirements should not be seen as a task imposed upon the SSI sector. Instead, it is a guideline intended to uplift the status of Indian drug SSIs. The revised Schedule M revision is needed for SSIs in self interest," he said.
Ashwini Kumar, DCGI, appreciated the efforts of IDMA (North Zone) and felt that the tremendous interest shown by the SSI sector to attend the workshop was the manifestation of the maturity of Indian small-scale drug manufacturing sector. He also placed the impending Schedule M norms in the context of the increased global presence of Indian pharmaceutical firms. Kumar assured drug SSIs that no genuine drug unit will be penalized for any inadvertent non-compliance of Schedule M even after January 1, 2005.
"By saying that the revised Schedule M is to be in place doesn't mean penal action against all defaulters. The compliance is going to be a joint effort where the regulatory authorities will be more of help. The industry should see the guidelines in a spirit of self-responsibility and its commitment towards society," he said.
Yogin Majmudar, president, IDMA and S V Veeramani, chairman SSI Sub-Committee, IDMA also spoke on the occasion. P K Gupta, chairman, IDMA (Haryana State Board) welcomed the gathering.
The technical sessions were prepared based on the feed back from the SSI sector on a questionnaire survey conducted by IDMA. The speakers and the topics respectively were A K Mitra, pharmaceutical consultant (Plant Layout), Ramesh Dharma, GM, SIDBI, Delhi (Financial Assistance), M Ramamoorthy, pharmaceutical consultant (Environment & Air Control), Kapil Bhargava CDSCO, Mumbai (Water for pharmaceutical use) and M Mitra CDSCO, Delhi (Validation and Documentation).
The IDMA had organized similar seminars in Mumbai, Chennai and Kolkotta during the last one year.