Dr Suresh K Muhammed, IPS, completes six months as drugs controller, of Karnataka state in mid-December. The doctor-turned-police officer who came on to head the drugs control department feels his assignment has been a challenge as his job symbolises the responsibility to end corruption, increase efficiency and sustain the standards to provide quality drugs at the right price.
The drugs controller aims to make the department a model for the country and is working towards achieving the National Accreditation Board for Testing and Calibration of Laboratories (NABL) accreditation. In a tête-à-tête with Nandita Vijay of Pharmabiz.com, Dr Kunhi Muhammed provides an insight into the changes introduced in the department. Excerpts:
What changes have you brought about after taking charge of this department?
There have been several changes made to improve the overall efficiency of the department and the aim is to become a 'model' department for the entire country. Safety, quality, efficiency and pricing of drugs are our top mandate. We are launching an intensive drive this month on Schedule H drugs with the pharmacy trade outlets.
We have formed the first-ever Consultative Committee for the drug-testing laboratory. The government has approved the levy of a fee for the issue of all types of certificates. The amount generated will be utilised to purchase computers and hire staff on part-time basis to speed up work. A team represented by officials from the drugs control department and pharmacy trade sector would submit a status report on the distribution of medical shops in the State.
The objective is to prevent the mushrooming of medical shops in areas where already enough number of shops exist. Then we can prevent the unethical practises in the pharma trade sector. We are keen to prepare the 'model' guidelines as we want the department to be the best in the country and the guidelines will be prepared on the basis of what suits best for our state.
What is your key thrust areas for the department?
The first task is to root out corruption. Secondly, there will be no room for inefficiency. Efficiency has improved by leaps and bounds at all levels despite obstacles like shortage of staff and computers. Thirdly, we need to control and stop groupism and indiscipline with a firm hand. If these things work out, then the department can become a model for the whole country.
What are the strategies chalked out to modernise the drugs department?
The drug test lab is a crucial part of our modernisation programme. Presently, there are no samples being held for more three months. The agenda is to test more samples, improve the testing methodologies and increase quality parameters. For the first time, internal audits of tests will be done where 10 per cent of all samples would be verified through an external auditor. We have approached the Drugs Control General of India (DCGI) for funds to open a world-class resource centre in the drug testing laboratory library.
The enforcement wing is doing routine inspection of all manufacturing units which is in addition to the mandatory evaluation for GMP (good manufacturing practices) certification or renewal of licenses or export clearances. During the inspections, drug samples are checked out at random to ensure that the units are maintaining standard quality parameters for both the domestic and international markets. An external watch over the drug inspectors is also being done. The number of prosecutions launched by the enforcement wing has increased manifold. At the same time we are becoming extremely customer-friendly and we are playing proactive role to improve the pharma trade and manufacturing business in the state.
What are the efforts in the area of computerisation of the department?
Computerisation is inevitable to speed up work. Currently, we have around 15 second-hand computers handed over from the directorate of health and family welfare. Under a central government grant, 12 new computers have just being installed in the department. The National Informatics Centre (NIC) is helping us to launch a web site. In future, we are planning to introduce online acceptance of manufacturing license applications. We also plan to launch a website for all the Assistant Drugs Controller offices in the interest of transparency.
As regards the drug test lab, with the setting up of the consultative committee, what are the focus areas and how soon do you expect improvement?
The focus of the department is the drugs testing lab. We want this lab to be the first accredited drug test facility in the country by NABL and we hope to achieve it. The Lab Consultative Committee is doing wonders for the lab as it has already laid down the standard operating procedures (SOPs) related to glassware, washing, storing chemicals etc. Training needs are being identified. We plan to initiate dialogue with the CII (Confederation of Indian Industry) Quality cell. The department has been selected for an intensive month-long training programme by the National Institute of Pharmaceutical Education and Research (NIPER), Chandigarh under a World Bank project from January 2004.
In addition, AstraZeneca and Biocon have agreed to train the chemists from the drug-testing laboratory on quality, maintenance and use of equipment, so that good laboratory practises (GLP) are followed. The GLP guidelines are already circulated to the drug test lab technicians.
It has been found that the State government's drug purchase department could be duped going by the stocks of spurious drugs unearthed in the primary health centres in the State and all of which have been tested at the State drugs control lab. In the wake of this scenario, what are the efforts to nab the spurious drug manufacturers in the districts?
We are awaiting the final Mashelkar Committee report to start the new initiatives. The Karnataka Drugs & Pharmaceuticals Manufacturers Association (KDPMA) is in the process of conducting a survey to ascertain the extent of spurious drugs production in the State and this could be a trendsetter for the country. To my knowledge, there is a serious problem and all the figures are exaggerated out without proper study. At the moment we are keeping a strict watch over such activities.
Could you briefly tell us the initiatives made in the area of blood banks?
We have intensified the vigil over blood banks particularly those in the private sector in the district headquarters. A circular has been issued to carry out weekly inspections and the Blood Bank Intelligence Wing will carry out an audit twice a week. With the help of the TTK Blood Bank, we have trained our enforcement staff recently and we hope to continue this training process for all the new enforcement officers.
What is the present status of old equipment and the old cold storage in the drug-testing lab, which is all lying unused?
A Condemnation Committee is set-up to study the need for condemning and disposing the old equipment including the cold storage, which does not function now. Before we get new cold storage equipment, we should condemn the old one. The Committee is headed by the superintendent of the lab and is represented by officials from the health and family welfare department also.
Has the state government given you an increase in funding to improve the prevailing condition in the stores?
The total drugs control department budget is Rs 8.5 crore, out of which 90 percent forms the salaries. Funds provided by the government are being utilised to the fullest extent. This time, we have received additional funding which is around Rs.10 lakh and another additional amount is expected.
How do you propose to handle the massive shortage of manpower in the department?
Government needs to be sympathetic towards the drugs department, which is responsible for the health of the people. Out of a current strength of 500 we have more than 100 vacancies. Within the constraints we are trying to do the best job. We hope to hire people on a part-time basis to tide over the manpower shortfall. Instead of groping in the darkness, we are trying to light a candle and do whatever is possible in the circumstances. We will not give up and are doing the best possible with the staff available.