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Curbing the Menace of Spurious Drugs
Dr G N Singh, DCGI , Ministry of Health, Government of India has taken a very hard stance on the menace of spurious drugs. In this exclusive interview with Pharma Bio World, the DCGI argues about the problem not being as alarming as it has been made out to be. Dr Singh has been very forthcoming to control the sales of spurious drugs and advocates active cooperation of all the stake holders including industry, public and NGOs in detection and reporting of cases of spurious drugs.

May we have your comments on the need to strengthen the policy for drug regulation to keep check on counterfeit drugs?
The term 'Counterfeit Drugs' does not figure in the Drugs and Cosmetics Act, 1940 and the Rules made thereunder. Under the Drugs and Cosmetics Act, a drug is considered as 'spurious drug' when it is deliberately manufactured, packed and mislabelled to conceal its identity, true character or the name of the manufacturer and the term spurious dug has been defined under the said Act. Under the said Act the manufacture, sale and distribution of drugs is primarily regulated by the State Drugs Control Authorities appointed by the State Governments. The term 'Counterfeit Medical Products' has been used in the international commerce and includes violations or dispute concerning of intellectual property rights also.
The statistics of the samples of drugs declared spurious during the last three years, out of the drug samples of suspected drug samples sent for test by the Drug Inspectors and tested by the Government drug testing laboratories reveals that extent of drugs declared spurious is around 0.3 per cent - 0.4 per cent. A survey to assess the extent of spurious drugs in the country was also conducted in the year 2009 by the Ministry of Health, through CDSCO. The survey has revealed that the extent of drugs found spurious was 0.045 per cent only. This indicates that the problem of spurious drugs in India is not as alarming as has been made out by the media. However, the reports of availability or detection of spurious drugs in the country do shake the confidence of the bias in the country as well as in the international trade.

What are major Concerns on Spurious Drugs?
The manufacture and sale of spurious drugs is a clandestine activity generally indulged in by anti-social elements and carried out by unlicensed or sometimes by the licensed manufacturers to exploit the confidence enjoyed by certain fast selling branded drugs by making their imitations. Being an undercover activity, it is difficult to detect the manufacture and movement of spurious drugs except by continuous surveillance by the State Drugs Control authorities, which are responsible for manufacture and sale of drugs in the State. Being an undercover activity, active co-operation from the law and order Enforcement machinery and other stakeholders like NGOs and public spirited individuals is essentials to contain the menace of spurious drugs.

You have initiated involvement of chemists to control the spurious drugs pouring into the market. To a certain extent this would help to control reaching such drugs to the consumers but how do you plan to crackdown on the manufacturers?
The drugs reach to the consumer only through the retail chemists and their involvement in controlling the spurious drugs entering into the market would go a long way in curbing the menace of spurious drugs. As the manufacture of spurious drugs is an isolated activity a continuous surveillance by the inspectorate staff of the State Drug Control Organisation can help in detecting the places where such drugs are manufactured and taking swift action in apprehending the persons involved with the help of the State enforcement authority.

Please apprise us on current regulation on counterfeit drugs.
In order to make punishment more deterrent for the offences relating to spurious drugs, the Drugs and Cosmetics Act, 1940 was amended in 2008 and it came into force on 10.08.2009. The salient features of the amendment are as under:
(a) Any drug deemed to be adulterated or spurious when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous shall be punishable with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more.

(b) The fi nes realised will be paid to the relative of the deceased or the aggrieved person.

(c) Offence for sale and manufacture of spurious and adulterated drugs have been made cognisable and non-bailable.

(d) A provision of compounding of minor offences has been introduced to dispose them of expeditiously.

(e) Designating special courts for trial of offences relating to Drugs and Cosmetics Act.

The Indian Government has announced Whistle Blower Scheme to encourage vigilant public participation in the detection of movement of spurious drugs in the country. Under this policy the informers would be suitably rewarded for providing concrete information in respect of movement of spurious drugs to the regulatory authorities which includes - reward of maximum of upto 20 per cent of the total cost of consignments seized will be payable to the informer/ officials which should not in any case exceed 25 Lakh in each case. However, in respect of an officer of the Government/CDSCO, the reward should not in any case exceed 5 Lakh for one case and a maximum of 30 Lakh in his/her entire service.
The Government of India is examining the feasibility of networking and tracking the drugs distribution system in the country from the manufacturer to the retailer to detect spurious drugs available in the market.

What kind of support would the central authorities require from the state governments and what are the loopholes that need to be plugged to implement the regulation?
The menace of spurious drugs can only be curbed through the system of continuous surveillance, strengthening of drugs control Departments establishment of drug testing laboratories and drawing and testing of reasonable numbers of samples of drugsand taking action against the offenders and above all active cooperation of the industry, public and NGOs in detection and reporting of cases of spurious drugs.

You have been very forthcoming for initiating the ban on over the counter sales of 92 antibiotics which has been going on for a very long time. How will this impact both pharma and healthcare industries? How do you plan to keep a check to ensure no OTC sales across the country?
A new Schedule H1 has been proposed to be introduced under the Drugs and Cosmetics Rules to include antibiotics, certain habit forming drugs and anti-TB drugs. With the strengthening of the State Drug regulatory infrastructure there will be more focus in regulating the sale of the drugs covered under the new Schedule.
This is more so required to contain the antibiotics resistance and misuse of certain habit forming drugs. Public awareness programmes about the proper use of such drugs in accordance with the prescription of the Physician are also required to be launched by the NGOs, media and other stakeholders.
Please tell us about the recent orders to pharmaceutical companies to submit safety details of new drugs within six months failing which their licenses will be cancelled.
The provision for submitting the safety reports of marketed new drugs are already enshrined under the Drugs and Cosmetics Rules and Schedule Y and these provisions are required to comply with companies permitted to market new drugs in the country. By and large the companies are submitting the requisite reports.

According to statement over 2000 people have died in the past four years during clinical trials and a parliamentary committee had hauled up CDSCO for several drugs being passed out without clinical trials. What does the law say in such cases and what measures have been taken by the government towards banning/ stopping their sale in the country?
Serious Adverse Events (SAEs) of death may occur during clinical trials due to various reasons. These could be disease related deaths like cancer etc or administration to critical or terminally ill patients or side-effects or unrelated causes. Such deaths are investigated for causal relationship by investigator and by the medical experts of sponsor. Further the Drugs and Cosmetics Rules are being further amended for making specific provisions in regard to the payment compensation to the trial subjects in case of injury or death due to clinical trial.
Key Challenges for Regulatory Authorities for Enforcing Regulations
Streng the ning of manpower and infrastructure both at the centre and State level.
Creation of drug testing facilities in the country, so that sufficient number of samples are drawn and tested in the country.
Training of drug regulatory officials in their respective fields.
Coordination between the States as well as with the centre for implementation of various provisions of the Drugs and Cosmetics Act and Rules.

In regard to granting of permission for manufacture/import of new drugs in the country without clinical trials in Indian patients, it may be that the Drugs and Cosmetics Rules and Schedule Y provides that under certain conditions the requirements of local clinical trials on Indian patients can be exempted for approval of a new drug in the country. The cases referred to in the Parliamentary Standing Committee report are under examination by the expert committee constituted by the Ministry of Health and Family Welfare.
Presently applications for approval of new drugs are examined in consultation with New Drug Advisory Committees. Decisions on exemption of local clinical trial before approval of any new drug are taken based on the recommendations of these committees.

Now that the government is in the process of formulating 12th Five Year Plan what kind of capacity augmentation of regulatory capacity is required in India at central and state levels?
The Government of India, Planning Commission constituted a working group on Drug and Food Regulation for the formulation of the 12th Five year plan (2012-2017). One of the terms of reference was to review the drug and food regulatory mechanism in the country to ensure providing quality, safe drugs and wholesome food in the country. The group considered the issue of strengthening of drug regulatory mechanism at the Centre and in the States in detail.
The Group summarised the issue and its main recommendations as - "Strengthening of drugs regulatory mechanisms in one of the major public health interventions. This ensures that safe, efficacious and quality drugs are made available to the people. Keeping in view the recommendations of the Mashelkar Committee, it is important that the infrastructure, both physical and human resource, both at the Centre as well as in the States is substantially augmented. A more transparent and effective monitoring of Clinical Trials is required. Regulation and control of all medical devices needs to be tightened. The proposed financial outlay for these activities is 6256 crore, for the Centre and the States which includes manpower augmentation, creation and upgradation of labs, setting up of new offices of drugs regulatory control, strengthening Pharmacovigilance and creating awareness among people (care givers and receivers) regarding safe drugs both at the Centre and in the States. For providing financial and human resources support to the State, a Centrally Sponsored Scheme is proposed."