Govt mandates GMP adoption for drugmakers with Rs 250 Cr turnover

New Delhi, Aug 3 (KNN) All the drugmakers with an annual turnover of over Rs 250 crore will now have to mandatorily adopt good manufacturing practices (GMP) within the next six months, Union Health Minister Mansukh Mandaviya informed on Wednesday.

The union minister in a press briefing informed that companies with a turnover of less than Rs 250 crore will be given a year to complete the process. “This timeline for completion of GMP norms begins on August 1,” Mandaviya said.

The Union minister said that Schedule M of the Drugs and Cosmetics Act has not been implemented properly by the majority of the drugmakers, but “that is going to change now.”

He added that those who do not follow the timelines will be penalised according to the provisions of the law after two reviews are conducted after a period of six months and one year. 

Schedule M of the Drugs and Cosmetics Act, 1940, deals with GMP for pharmaceutical manufacturing units, including specific requirements pertaining to premises, plant and equipment.

GMP are mandatory standards which build and bring quality into product by way of control on materials, methods, machines, processes, personnel and facility or environment etc. 

At present, there are around 10,500 manufacturing units in the country, of which around 8,500 fall under micro, small and medium level enterprises, or MSMEs.  

“We have around 2,000 units in the MSME category in the country having WHO GMP certification,” the ministry said in its statement.

According to the statement, drug regulators are as part of a drive to crack down on faulty drugmakers. The government’s inspection cracked down on 162 units and 14 public testing labs over the last six months. 

Major issues detected during these inspections included poor documentation, lack of process and analytical validations, absence of self-assessment, absence of quality failure investigation, absence of internal product quality review, absence of testing of incoming raw material amongst others.

“Based on these factors and to keep pace with fast changing manufacturing and quality domain, there was a necessity to revisit and revise the principles and concept of GMP mentioned in current Schedule M,” the ministry said.

This move by the government will bring the GMP recommendations and compliance expectations at par with global standards, especially to those of WHO, and ensure production of globally acceptable quality of drug.  (KNN Bureau)