RAGPICKERS in Chennai and its suburbs were in for a surprise when they reached the dumping yards sometime in the middle of March. Along with wastepaper, discarded polythene sachets, rubber goods and plastic articles were huge quantities of medicines in vials, tubes, bottles and strips. It soon came to be known that spurious and time-barred drugs had found their way to open grounds, dumping yards, roadsides and lake bunds in different parts of Tamil Nadu following a crackdown by the government on what turned out to be an illegal pharmaceutical supply chain.
The illegal trade brought disrepute to the State, which has been making great strides in the manufacture and distribution of drugs. There were 697 units manufacturing allopathic drugs, 14 making homoeopathic medicines, and 113 producing cosmetics, besides 42,271 retail medical outlets in the State, as on October 31, 2009.
The authorities admitted that the sale of spurious drugs had been going on for some years. Though the government has taken steps to allay the apprehension of the public over the issue, panic still prevails over the genuineness of the medicines it buys from the pharmacies. The issue rocked the State Assembly on April 7 when the opposition All India Anna Dravida Munnetra Kazhagam demanded the resignation of Health Minister M.R.K. Panneerselvam owning moral responsibility for the unchecked sale of fake and time-barred drugs across the State. Other opposition parties the Congress, the Pattali Makkal Katchi, the Communist Party of India (Marxist), the Communist Party of India, the Marumalarchi Dravida Munnetra Kazhagam and the Viduthalai Chiruthaigal Katchi demanded stern action against those involved in the drug scam.
The case was transferred to the Crime Branch (Criminal Investigation Department), or CB-CID, of the State on April 3. The police and the revenue and drug control directorates, which conducted joint raids in Chennai and other parts of the State, seized fake and expired drugs worth several lakhs of rupees. In one of these operations, the city police seized drugs worth Rs.1 crore from Purasawalkam in Chennai on March 24.
The investigating agencies played their cards close to the chest as several theories did the rounds about what appeared to be an inter-State drug racket. We do not want to leave anything to chance. However, indications are that the scam has inter-State ramifications. The network spreads to areas, including Delhi, Andhra Pradesh, Karnataka and Puducherry, said an official source.
Chief Minister M. Karunanidhi said the Dravida Munnetra Kazhagam (DMK) government would not hesitate to demand a probe into the scam by the Central Bureau of Investigation (CBI) if it had multi-State ramifications. Political observers said the fact that Karunanidhi himself replied to a call-attention motion in the House showed the importance he attached to it. The fact that the manufacture of medicines comes under the Union Ministry of Petroleum and Fertilizers held by Karunanidhis son M.K. Azhagiri enhanced the anxiety of the treasury benches, they pointed out.
The police arrested 28 people, 11 of whom were detained under the Goondas Act. The key suspects include Meenakshi Sundaram, of Meena Health Care Private Limited, and Sanjay Kumar and Pradeep Chordia. Meenakshi Sundaram, a stockist, had a case registered against him in 2001 for selling medicines without a licence, the police said.
Rejecting the plea of Meenakshi Sundaram and four others for anticipatory bail, a sessions court on March 25 expressed grave concern at the manner in which discarded drugs were retrieved from dumping yards and repackaged for sale after the batch number and the expiry date were tampered with. In another development, the Madras High Court on March 30 directed the authorities concerned to take stern action against fake medical practitioners and people who ran dispensaries that sold time-barred medicines.
Rackets in spurious drugs have had their victims sporadically in the past. In December last year, a three-year-old girl of Pulianthope in Chennai died after she was allegedly given time-barred drugs for fever. Her parents lodged a complaint with the police in this regard. Much ahead of this incident, the Directorate of Drug Control (DDC) had come to know of the circulation of a spurious drug to treat irregular, painful or heavy periods. The case was handed over to the CB-CID in August 2009.
The investigations in spurious drug cases took a significant turn after the personnel of the DDC found a large stock of time-barred and fake drugs in an apartment in Purasawalkam on March 11. It gave the authorities important leads to a network of operators who circulated spurious drugs, breaking the normal cycle of manufacture and distribution. Among the seized articles were drug labels, injections, syringes, antibiotics, anti-hypertension pills, anti-inflammatory drugs, ointments for burns and cut injuries, protein supplements and cough syrups.
Since then events unfolded so fast that it became difficult for one to comprehend the intricacies of the problem. Even as raids were conducted at manufacturing units, warehouses of wholesalers and retailers, and medical shops in different parts of the State, the Chief Minister convened a high-level meeting of officials, on March 22, to take stock of the situation arising out of the seizures. He asked the police and the Health Department to intensify the drive and catch the people involved in the production of fake drugs and the recycling of expired medicines.
Investigations revealed that truckloads of counterfeit and time-barred medicines were moved out from wholesale godowns to retail outlets after being made to appear genuine with the use of sophisticated technology in printing and packaging. Expired drugs from junkyards were also collected and recirculated after fresh expiry dates and batch numbers were printed on them, the investigators said.
The busting of the drug racket exposed several lacunae in the drug control mechanism in the State besides bringing to the fore the nexus between manufacturers of spurious drugs and the authorities concerned, the suspected political patronage for this illegal activity, and the unethical practices employed by pharmaceutical companies to push their products.
For instance, the scam brought to light the sorry state of affairs in the State Drugs Control Administration. Until the appointment of a Director in September last year, the DDC had no regular head for nearly 10 years. The directorate was also heavily understaffed: until recently it had 50 drug inspectors for the whole State against the sanctioned strength of 75. The lone Drugs Testing Laboratory in Chennai, too, was inadequately staffed.
The rags-to-riches story of some of the prime suspects shows the alarming rate at which the spurious drug trade has been growing. Though confusion prevails in assessing the scale of counterfeit drugs manufactured and circulated in the country, the Central government has put it at 0.3-0.4 per cent of the pharmaceutical industrys annual turnover of Rs.75,000 crore. Some experts, using 2001 statistics ascribed to the World Health Organisation, say 35 per cent of the worlds spurious drugs are produced in India. However, others point out that the WHO, in a letter to the Government of India in August 2003, clarified that it had not conducted any such study.
V.K. Subburaj, Principal Secretary (Health and Family Welfare) to the Tamil Nadu government, highlighted the various steps taken by the government to stem the rot. He said pharmaceutical manufacturers in the State had been asked to follow the prescribed procedure in taking back expired drugs and in their disposal. Retailers had been asked to appoint full-time pharmacists at the outlets, he said. Apart from sensitising wholesalers and retailers on the norms to be adopted in the business, the government had taken steps to create public awareness on the issue, Subburaj said. He warned that those who violate the law and play with the lives of the people, in spite of all these administrative measures, will be dealt with an iron hand. According to an amendment of the Drugs and Cosmetics Act, 1940, which was notified on August 10, 2009, the penalty for manufacturing spurious drugs has been increased substantially, to a minimum imprisonment of 10 years that may be extended to life term and a minimum fine of Rs.10 lakh or three times the value of the confiscated drugs, whichever is higher. Subburaj said the violators of the law would be dealt with according to the provisions in the Act. The Chief Minister pointed out that some of the offenders on previous occasions were awarded only nominal punishment such as a penalty of up to Rs.7,000 and imprisonment until the rising of the court.
Subburaj put part of the blame for the collapse of the drug cycle involving manufacture, distribution and safe disposal of time-barred medicines on manufacturers who authorised others to carry out the task of disposing of expired drugs. Denying that lack of incinerators had contributed to the recirculation of expired drugs in the market, he said it would not be a big problem for the multi-crore manufacturing units to install incinerators.
He said the government had written to the High Court pleading for the appointment of special courts for speedy trials as around 500 drug-related cases were pending before the courts. Subburaj added that steps were also taken to fill vacancies in the DDC, which started functioning as a separate department from November 1981. We are in the process of creating additional posts to cope with the increasing workload.
M. Baskaran, Director, DDC, said surprise raids conducted at 3,000 retail outlets throughout the State from March 22 to 29 revealed just about five violations, and there was no need to panic. In the past three years, of the 670 sanctions for prosecution accorded, only around 20 cases were related to the sale of time-barred drugs, he pointed out.
He said that even with the limited number of personnel, the directorate was able to unearth between August 2009 and March 20 this year spurious drugs containing norethisterone and the counterfeiting of a cough syrup and a fast moving medicine for cardiac problems. The manufacturers in the State have been asked to take corrective steps. If they violate relevant laws and procedures, they will not be allowed to run the units. In the last three years alone, around 90 erring units have been closed, he said.
Tamil Nadus share in drug export is Rs.3,500 crore, which accounts for 10 per cent of the medicine exported by the country, and the value of drugs produced in the State annually is Rs.6,000 crore, he said.
R. Ramesh Sundar, general secretary of the Tamil Nadu Medical and Sales Representatives Association, said what the authorities had unearthed so far was only the tip of the iceberg. Describing the drive against the misuse of licences, recycling of expired drugs and selling of fake medicines as steps taken in the right direction, he urged the government to focus its attention also on other areas of concern in the pharmaceutical industry: unscientific and irrational combinations of medicines, over-invoicing, and flouting of rules with regard to fixing the price of drugs.
Taking advantage of the excise duty holiday declared by certain States, including Himachal Pradesh and Uttarakhand, signboard drug manufacturing units had mushroomed, contributing in a big way to the growth of counterfeit medicines, he alleged. Ramesh Sundar also flayed certain pharmaceutical companies for the unethical marketing practices they employed to push their products.
Some experts are also dismayed at the new-found interest of some politically influential people in the money-spinning health sector. They say the spurious drug business cannot flourish without the support of these influential sections.
Dr C.S. Rex Sargunam, former Director of the Institute of Child Health and president of the Tamil Nadu Health Development Forum, said nothing substantial had been done with regard to the manufacture and sale of spurious drugs that caused serious side effects. Several manufacturers outsourced the production processes in order to cut costs and merely put their labels on the packets, he said, adding that the government should not give licences to people who did not have the necessary qualification or expertise to start manufacturing units.
Dr Rex emphasised the urgent need to shift the drug industry from the Ministry of Petroleum and Fertilizers to the Ministry of Health. This, along with measures to enhance health and hygiene in the country, would go a long way in ending the lopsided priorities in the field of public health, he said. Claiming that the drug control mechanism in the country was in bad shape, he stressed the need for effective coordination between the Central drug control agency and the DDCs.
He also called for steps to ensure that results of tests done by the Drugs Testing Laboratory were furnished within three weeks. Though the number of basic essential drugs did not exceed 300, several thousands of irrational combinations were being circulated, he said. He asked the government not to allow these drugs. He suggested that the drug control administration in the country should elicit the views of competent professionals before allowing the manufacture and sale of drugs. Dr Rex asked the government to support the professional bodies of medical personnel so as to prevent them from depending on pharmaceutical companies to run medical journals or hold conferences.
It is a shocking revelation that a racket of this magnitude has been going on, and that too in Tamil Nadu, said T.S. Jaishankar, chairman, Confederation of Indian Pharmaceutical Industry. The State always had a reputation for manufacturing good-quality products and this issue will greatly affect the industry, though no manufacturer is involved.
With a view to eradicating fake and time-barred drugs, he suggested that the product label should have the name of the medicine and the expiry date printed clearly in bold fonts. He said that consumers should buy full strips with the name of the medicine and the expiry date, and should always insist on a bill. He also called upon retail pharmacists not to change the prescribed medicine on their own and push products of their interest. Jaishankar has also proposed an amendment of the Drugs and Cosmetics Act to ensure incineration of time-barred drugs within one year of expiry.
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