The Madhya Pradesh Small Drug Manufacturers Association (MPSDMA) has trained guns on the large-scale manufacturers and corporates who have opted for loan licences for drugs, even after owning large manufacturing facilities.
The MPSDMA office-bearers claim that the loan licences have been distributed on ad-hoc basis against the Drugs and Cosmetic Rules, 1945. They have written letters to the Drug Controller General of India, and different state drug authorities to darn the irregularities.
In a letter (MPSDMA/36/02-03) to Ashwini Kumar, Drug Controller General of India, the Association office-bearers have drawn attention to Explanation to Rule 69A and 75A of Drugs and Cosmetics Rules 1945, and said that the corporates which own manufacturing facilities cannot be issued loan licences. But, the Rules are not being followed, they pointed out.
According to Rule 69A -- "Explanation - For the purpose of this Rule a Loan licence means a licence which a Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail him-self of the manufacturing facilities owned by a Licencee in form 25."
Also the Rule 75A suggests -- "Explanation - For the purpose of this Rule, a Loan Licence means a licence which a Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail him-self of the manufacturing facilities owned by another Licencee in Form 28."
"It is being observed that many of large-scale, PSU's and MNC's having their own manufacturing facilities, are being granted/renewed licences contrary to these provisions,'' stated the office-bearers, requesting that all state drug authorities may be instructed that all such loan licences either granted or renewed against the authority of statutory Law, may be cancelled without any delay.
According to J R Agrawal, President, MPSDMA, similar letters have gone to most of the state drug authorities where such irregularities have surfaced, but nothing has transpired. The drug authorities have not even responded to issue. ``In case a small drug manufacturers was caught in such a web, he would have been penalized by now," he opined.