The Andhra Pradesh Drug Control Administration (APDCA) has the onus to control a large number of pharma manufacturing units in the country. The state is the home to more than 1700 pharma units engaged in formulations and bulk drugs manufacturing business. The APDCA is undergoing a high-speed modernisation process in an effort to enhance its regulatory activities. In an e-mail interview to Gireesh Babu, R P Meena IPS, Director General of APDCA elaborates the recent developments in the state drug regulatory mechanism. Excerpts:
Could you brief us on the latest initiatives in the Andhra Pradesh Drug Control Administration?
Drugs testing laboratories at Hyderabad and Vijayawada are going to be upgraded with NABL accreditation with an amount of Rs 10 crore funded by DFID programme. Drugs inspectors are going to be recruited shortly through AP Public Service Commission. Under DFID programme, communication would be improved by providing cell phones to all officers and fax machines to all offices in the state. Transport facilities for officers are improved by providing 50 four wheelers to them in the state.
Every month, 350 samples are drawing from underserved areas and remote areas apart from regular samples of 400 samples. Assistant director is made in-charge of each district to supervise the work of drugs inspectors and to issue sales licences. Two joint directors post are sanctioned by the government in enforcement wing in addition to the existing one joint director and one director. It is proposed to notify all these four officers as manufacturing licensing authorities and controlling authorities to speed up the work related to manufacture of the drugs in the state.
Could you give us a brief idea about the pharma industry in Andhra Pradesh in a regulator's view?
There were only 28319 sales licences and 1585 manufacturing licences as on 2000. Now the trade and industry are increased and at present there are about 50238 sales licences and 1703 manufacturing units concerns in the state (up to March, 2009). These concerns are to be inspected by the drugs inspectors on regular basis to ensure the manufacturing of qualitative drugs as well as the availability of qualitative medicines in the market as per the rates fixed by the government of India.
What is the current status of your efforts to strengthen the DCA headcount?
No new posts have been sanctioned in the department for the last 10 years. But, during the year 2007-08, the government was kind enough and have sanctioned 6 posts of assistant directors and 50 posts of drugs inspectors. All the six posts of assistant directors have been filled up and for filling the 50 posts of drugs inspectors the AP Public Service Commission has been requested to take up the task. The notification has been issued by the AP Public Service Commission in this regard. To further strengthen the drugs control administration, government has sanctioned 2 posts of joint directors, 6 posts of deputy directors, 15 posts of assistant directors and 25 posts of drugs on enforcement side. All the posts like 2 joint directors 4 posts of deputy directors, 21 posts of assistant directors have been filled by promotion and filling the posts of 25 drugs inspectors is under process. Now the enforcement officers are increased and it is almost double the existing officers.
How many drug sample tests have been conducted by the APDCA in last one year and how many are found not of standard and spurious? What is the current status of your actions against the erring units?
During the last five years (from 2004-05 to 2008-09) as many as 23287 samples have been analysed in both the drugs control laboratories at Hyderabad and Vijayawada. Out of this 454 drug samples have been found to be not of standard quality (NSQ) during the years. NSQ drugs prevailing in the state is less than 2% and it is far below of National average 6 to 8%. The prevalence of spurious drugs in the state is 0.21% where as national average is 0.47%.
During the last five years, as many as 535 cases have been filed in the various courts under various Acts, of which 234 cases have ended in convictions during last five years. The sentence of imprisonment ranges from one year to 5 years.
During 2007-2008 & 2008-2009, large quantities of spurious drugs, drugs manufactured without valid drug licence, physician samples not for sale and drugs marked as government supply were seized to a tune of Rs7.61 crore and Rs 1.97 crore, respectively. Further, the fixed dose combinations unapproved by Drugs Controller General (India) are recalled from the market to a tune of Rs 38.00 crore at various levels.
In March 2009, APDCA has booked the state-owned drug distribution body for passing on a recalled product through primary health centre. Do you think that the current pharma product recalling system in India is well functioning? Explain
The present system of recall of NSQ drugs is not effective. The department officers are now provided with cell phones and fax machines to communicate among them freely. The department is also planning to have a website to inform the details of NSQ and other vital information to the stakeholders and public at large. Instructions are issued to track the movement of NSQ and spurious drugs in the market with proper documentation and to report in time.