The office of the Drug Controller General of India (DCGI) is determined to go ahead with the process of weeding out all irrational combinations from the Indian pharmaceutical market soon. This would happen even if some of the pharmaceutical companies are constantly trying to oppose the government's initiative, according to Dr GN Singh, the DCGI.

Speaking to Pharmabiz on the sidelines of a meeting organised as part of Pharmacy Week celebration in Chennai, the national regulator said his office is now formulating a special strategy to clean the Indian pharma market giving no space for irrational combinations. However, Dr Singh did not explain how would the strategy be worked out and what it was. He added that provided the pharma companies failed to submit the safety and efficacy data, all the fixed dose combination drugs  would be banned in the country.

In January this year, DCGI issued his second directive in this regard to the state licensing authorities seeking the safety and efficacy of fixed dose combinations from the manufacturing companies, and put September 30 as the last date for submission of the data. Later, he preponed the deadline to August 30. Soon, the manufacturing body from Himachal Pradesh approached their High Court and got a stay order for this directive.

Similarly, the first attempt of the DCGI to remove all the irrational and harmful combinations from the market was also thwarted by the drug makers when it was issued in 2007 by challenging the order in the Madras High Court. The case is still pending with the court.

When asked about the status of the dossiers he received so far, DCGI said not all the companies have so far submitted the safety documents, there are even certain companies to comply with his order. “The dossiers we have received are under scrutiny. Phasing out of irrational combinations will be carried out in a time bound manner. As the national regulator of the country, it is my duty to maintain the safety and efficacy of drugs. We are committed to ensure the safety of patients.  We will weed out all irrational combinations,” said Dr Singh.

Regarding the case pending with the Madras High Court and the recent stay order for his second directive from Himachal Pradesh High Court, Dr Singh commented “India is a democratic country and we are for giving justice to the people”.

In the case of Pondicherry issue, where certain manufacturing companies have started making of combination drugs without the approval of drug controller general, he said every state regulatory authority should comply the national regulator’s rules. In Pondicherry also, the state authorities will comply with his rules, he hoped.

Earlier, while delivering the key note address in the pharmacy week celebration meeting, Dr Singh said pharmacists have a pivotal role in making quality medicines. They are health care providers. Twenty first century will bring major changes in the pharmacy profession.

The DCGI gave away the ‘Best Pharmacist Award’ to M Sulaiman, managing director of Madras Pharmaceuticals. Tamil Nadu IPA president MM Yusuf, secretary, J Jayaseelan, IDMA president elect S Veeramani, state drugs controller, Abdul Khader, associate professor of Pharmacy from US Christine Birnie and CDSCO deputy drugs controller S Manivannan attended the meeting.