IDMA demands rollback of proposal to make annual joint inspection of drug units mandatory

Mumbai, June 2017:

The Indian Drug Manufacturers' Association (IDMA) has urged Union health ministry to rollback the proposed amendment to the Drugs and Cosmetics Rules, 1945 seeking to introduce mandatory requirement of joint inspections before grant of license and of licensed manufacturers. The proposed move will introduce dual control leading to delay and undue hardship to the applicants and licensees, said the industry body.

The ministry had on March 31, 2017 issued a draft notification seeking to amend Drugs and Cosmetics Rules, 1945 to provide for perpetual licenses and joint inspections. As per the notification, the manufacturing and selling licenses will be valid permanently unless suspended or cancelled. However, licensee will have to pay retention fee before expiry of license every succeeding five years from the date of issue of license. The circular further proposed to inspection of manufacturing facility jointly by state and central drug inspectors before grant of license. It makes joint inspection once in a year mandatory.

While welcoming the government initiative to issue licenses permanently, the IDMA has expressed reservation over the proposed introduction of Rule 73AB, Rule 84C, Rule 143A which provides for joint inspection before grant of license and compulsory annual joint inspections of licensed manufacturers. This will result in unnecessary delay and hardship to the applicants wishing to set up pharma unit and also to the existing industry.

The proposal is inconsistent with the provisions of the Drugs and Cosmetics Act, 1940. Currently the work of grant and renewal of manufacturing licenses, grant of additional products, issue of various certificates required for tender and export, continuous monitoring of activity of manufacturers is being done by state licensing authorities in an efficient and timely manner without compromising GMP requirements of the Act and thereby promoting industry.

The concept of joint inspection will lead to dual control and will hamper the ability of state licensing authority to perform its above mentioned duty. The coordination between state and central officers will be difficult for units at district and far away places as CDSCO's presence is only in metros while the state officers are available at every district in most of the states.

At present there are more than 10,000 manufacturing units in the country. With the limitations of manpower with regulatory authorities both state and central, mandatory joint annual inspection of the sites would be a herculean and almost impossible task.

Considering this, DCGI has issued directions to manufacturers to self-assess their compliance with good manufacturing and good laboratory practices (GMPs/GLPs). Manufacturers were directed to carry out self-assessment, based on the check-list and award themselves a quality rating by benchmarking and submit the resulting report to the relevant regulatory officials. The activities of 1330 WHO-GMP certified units contributing to bulk of domestic and export requirement are constantly monitored jointly by CDSCO and state drug inspectors.

In view of above, the IDMA submitted that instead of making it legally mandatory for joint inspections once in a year, measures like self assessment and risk based inspections initiated recently should be pursued to ensure effective quality management.

Instead of thinly spreading the already limited resources in carrying out the inspections of all the manufacturing units, the focus should be on strengthening of state and central regulatory machinery in terms of manpower, skill development and infrastructure, it concluded.