The Union government’s latest amendment to the Drugs and Cosmetics Rules 1945, which has rubbed upstate drug control officials in the wrong way, could slow down the licensing process for manufacturing units.
According to the notification issued by the Drug Controller General of India (DCGI), which was sent to all states and Union territories on November 24, the sites should be inspected together by the central and state drug inspectors previously conceding a licence to a drug or cosmetic manufacturing unit.
“The premises licensed might be inspected together to check consistency with the conditions of the licence and the provisions of the Act and the Rules at the very least once in three years or as required according to a risk-based approach,” it says.
About the central drug authority’s while a section of the industry is concerned due to the lack of manpower to conduct timely joint inspections with their state partners, and state drug controllers.
“The entire amendment is unwarranted. Move to conduct joint inspections won’t serve any need and may just delay the licensing process. Also, the officials originating from the Center may not know about local issues and sensitivities. This will just make additional bottlenecks,” a retired drug controller said on condition of anonymity.
At present, the Central Drugs Standard Control Organization (CDSCO) handles licensing work such as approvals implied for the manufacture of large volume parenteral, vaccine and sera, blood bank and blood components, medical devices and products manufactured by recombinant innovation.
It also manages new drug clearance, clinical trials, import registration, and inspections. Then again, the state drug controller manages to license of both manufacturing and sales premises of drugs and cosmetics.
“For this reason the central government doesn’t have enough staff. With the state officials waiting for the central authorities participation in each inspection, the licensing process may get postponed,” Atul Kulkarni, General Manager Quality of Sree Krishna Pharmaceuticals, a Hyderabad-based bulk drug manufacturing firm.
Anyhow, not all are against the new amendment. “This is an appreciated step in certain northern states where officials don’t have the expertise to direct appropriate inspections.
The progression will help improve quality under such conditions,” an industry campaign group representative opined.
The decision to make joint inspections mandatory is seen by many state officials as an intrusion into state government’s powers.
All India Drugs Control Officers Confederation (AIDCOC), an association of drug control officers of different state governments, has effectively moved the court against the measure.
“The autonomy given to the state government officers would disappear if the amendments take effect,” another senior official pointed out.