The All India Drug Control Officers Confederation (AIDCOC), an association of state and central drug control officers in the country, is opposing the industry's demand to legalise the guidelines attached to the Spurious Drugs Act. The AIDCOC has sought the enactment of the Act at its present form.
On the industry's demand, the Union Health Ministry had issued a set of guidelines to be followed by the state drug control organisations while acting against the offenders. The government's action in this regard was to safeguard the interests of the genuine drug manufacturers. However, the guideline comes as an offence against the genuineness of the drug inspectors and dilutes the whole spirit of the new Act, says Ravi Udaybhaskar, secretary general, AIDCOC.
“We have expressed our concerns on the guideline to the DCGI (Drug Controller General of India). What is the use of a guideline to the drug inspectors when the Act itself specifies the proceedings? Why does industry think that the Act will be misused by the investigators, while they have all the platforms available for redressal? We will oppose this move when the issue comes to the Drugs Technical Advisory Board,” said Udaybhaskar.
The guideline classifies the defects in pharmaceutical products as three categories, A, B and C. The spurious and adulterated drugs are classified under category A, grossly substandard drugs as category B and minor defects like broken or chipped tablets, cracking of emulsions, change in colour of the formulation under category C. The Category B and C are defined further in order to avoid false categorisation of defects.
In case of not of standard quality reports based on minor defects arising out of variations from the prescribed standards of contraventions, the authority may be resorted to measures including suspension, cancellation or compounding offences and launch prosecution only if it is justifiably felt that above measures would not meet the ends of justice.
Industry associations like Indian Drug Manufacturers Association (IDMA) has been advocating for legalisation of the guidelines to prevent the misuse of the law under which manufacturing and marketing of spurious drug is a cognisable and non-bailable offence with a penalty upto Rs 10 lakh and imprisonment upto 10 years.
The IDMA leaders earlier raised their apprehension that since the rational measures suggested by the ministry is only a guideline, the industry fears that the state regulators are not mandated to follow the mentioned procedures while taking action in various cases.
Lately, the DCGI has started initiatives to notify the guidelines to avoid unnecessary harassment to genuine drug manufacturers by the drug inspectors. The office has already identified the appropriate provisions in the Drugs and Cosmetics Act under which the guidelines will be made binding on the drug inspectors.