The Drugs Control Department of the National Capital Territory of Delhi is one of the pro-active state drug regulatory authorities in the country. Committed to weed out spurious / unlicensed drug trade from its territory, the authority has been making extra efforts to keep a watch on all suspected elements operating in the state. It has set up Intelligence cum Legal Cell headed by one Assistant. Drugs Controller specifically to curb the menace of spurious and adulterated drugs.

The authority has drawn long term plans to put an end to the unlicensed and illegal trade of drugs in the state. It is in the process of upgrading its drug testing facilities, speeding up the clearances of drug licences, strengthening its vigil over any possible movement of sub-standard or spurious drugs and also computerizing its operations. In an exclusive interview with Chronicle Pharmabiz, Dr C M Khanijo, the Drugs Controller of Delhi spoke at length about the plans and programmes of his department. Excerpts:

Delhi is often seen a major transit point for spurious / sub-standard drugs. Do you agree with this perception? What are major concerns of the department in this regard?
The number of spurious drugs traced during the last three years is 7, 36 and 18 respectively. This statistics has been drawn from the test results of drugs confiscated during all special operations as well as routine inspections conducted during the period.

The perception and prevalence of spurious drugs is a debatable issue. No manufacturing unit in Delhi has been caught indulged in the manufacture of spurious drugs during recent years. Delhi is one of the country's biggest trading centre for drugs. Delhi has a higher risk of penetration of spurious drugs as it is one of the biggest transit point of drugs. During the last three years, only five licensed dealers were found to be dealing with spurious drugs. While four of them were into wholesale business, one was a retailer. Prosecution measures have been initiated against all of them.

It's the sale of drug without prescription or bill that is troubling us more. It should also be understood that there is a heightened possibility of the presence of spurious drugs when the sale is done without proper records. However, this issue is multi-pronged and should be addressed with the support of other departments like the sales tax department.

What are the measures taken by the department to ensure the production, distribution and sale of quality drugs in the state?
We are planning to conduct an independent assessment of the spurious drug situation in the state. We will assess the prevalence of spurious or look-alike products in the state and then plan more focused long-term measures to prevent / reduce the incidence of such illegal activities. Sale of drugs without prescription or sale invoice will be seriously monitored.

We are taking legal samples to check the quality of drugs of even multinational companies. It's an equal mix of local as well as national + international companies. The equal mix of companies is there not without reason. It helps us analyze the quality of drugs that are moving in the market.

Department had suspended 800 sale licences during the last one year. We collect samples of fast moving drugs; look for the purchase bills of the chemist of all the medicines that have been picked up.

In addition to legal samples, we do survey sampling. Legal survey is taken on the basis of the sample survey. From Bhagirath place alone, we have taken 742 samples from 300 chemist shops. Out of these samples, 22 of them were found to be substandard, but none were spurious.

All samples from special raids / police operations are sent to the central lab for testing. Since January, Delhi Drugs Control Department has carried out 23 seizures. While nineteen of them were unlicensed chemists, others were unlicensed cosmetics manufacturers. Stocks from unlicensed premises, godowns, shops etc were the ones that were seized during the raids.

Are you planning any public awareness programme in this regard?
A multi-pronged strategy to create awareness is taking place at the government level. IEC (Information Education Communication) programmes are being planned. We have planned advertisements in all leading dailies (16 dailies) insisting on public awareness and education. The government intends to go for frequent IEC programmes. The advertisements will advise the public against self-medication. It will remind them to ask for bills, and caution them against the practice of brand replacement by chemists.

The "know your pharmacist" boards with photo of the person on whose name the sale licence is issued has been made mandatory in all medical shops. Though there are resistance from some pockets, the move, by and large has been successful.

We have joined hands with Delhi Pharmacy Council for preparing a database of all registered pharmacists in the state. This is meant to have a control over the pharmacists who are hopping frequently from one place to another. The whole process should be over within six months from now.

Interestingly, all the sale licences issued by the department during the last three months carry photographs of the licence holder. The department is also asking the chemists to display common messages in their shops. These messages will carry the same advices that are being conveyed through the advertisements. The department is to supply self-sticking posters carrying the message to all retail chemists in the state.

How efficient is the functioning of the state drug-testing laboratory?
The drug-testing lab of the state government is being strengthened as per a central programme. The lab is testing 1500 samples a year. The last year, the department tested 2545 samples. The tests were conducted with the help of central laboratory also. The department have also taken 17,00 laboratory samples during the last year. The previous year it was 1200.

As a strategy, the department has decided to reduce the collection of samples until the pending ones are cleared. If the samples are analyzed within five months or so today, we will ensure that it gets cleared within two to four weeks within a short time. Once the pending applications are cleared, things can be easily streamlined.

In what stage is your computerization programme?
We are developing an online licensing system where the applicant can know the status of his application online. The process of vetting the software is on. In addition to this there would be a complaint redressal system. Dealers and the general public can submit their complaints online. Applications for both renewal and fresh sale licences can be downloaded from our website. The status of each application can be checked, and the whole task of licensing process will be eased within a short period. The department website would undergo an upgradation and the applicant would be able to check for any deficiencies in his application online. Inspection status will be available and it is going to be very transparent.

All procedures are on the web even now. The aim is to make it more interactive, people friendly. We will be able to do it within three to four months. We are also part of the capacity building programme of the CDSCO. The software developed as part of this programme is based on the district pattern. In Delhi we are following a zonal pattern. The software, which we are developing, will suit to our needs and will later be converted to the central pattern.

How do you intend to address the issue of inadequate staff strength? What is the current status of pending licence renewal / fresh applications?
The Department has requested the Delhi Government to sanction funds for the strengthening of the department and also for the appointment of additional staff. It is part of the government's five-year plan and the amount is to be sanctioned soon. At present we have 29 inspectors. This includes 2 deputy drug controllers, 5 assistant drug controllers and 19 drug inspectors. In the last three months we have issued more than 5,000 retail licences that is a record in itself. Almost 98 % of the renewal of sale licences is over. In the case of manufacturing licences, almost all pending applications are likely to be cleared soon. It's not the computerization that is bringing in all the changes, it's the change in mindset.